Pharmacokinetic Study With an Oral Suspension of Perampan... | NCT02914314 | Trialant
NCT02914314
Sponsor
Eisai Inc.
Status
Completed
Last Update Posted
Mar 15, 2024Actual
Enrollment
26Actual
Phase
Phase 2
Conditions
Epilepsy
Interventions
perampanel
Countries
United States
Latvia
Protocol Section
Identification Module
NCT ID
NCT02914314
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
E2007-G000-238
Secondary IDs
Not provided
Brief Title
Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy
Official Title
An Open-Label Study With an Extension Phase to Evaluate the Pharmacokinetics of Perampanel (E2007) Oral Suspension When Given as an Adjunctive Therapy in Subjects From 1 Month to Less Than 4 Years of Age With Epilepsy
Acronym
Not provided
Organization
Eisai Inc.INDUSTRY
Status Module
Record Verification Date
May 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 20, 2017Actual
Primary Completion Date
Aug 23, 2022Actual
Completion Date
Apr 25, 2023Actual
First Submitted Date
May 26, 2016
First Submission Date that Met QC Criteria
Sep 22, 2016
First Posted Date
Sep 26, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 22, 2023
Results First Submitted that Met QC Criteria
Aug 22, 2023
Results First Posted Date
Sep 15, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 15, 2024
Last Update Posted Date
Mar 15, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eisai Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of perampanel during the Maintenance Period of the Core Study following oral suspension administration given as an adjunctive therapy in pediatric participants from 1 month to less than 4 years of age with epilepsy.
Detailed Description
This is a multicenter, open-label study comprised of pretreatment, treatment (core study), and extension phases that is designed to evaluate the PK of an oral suspension of perampanel (maximum dose must not exceed 12 milligrams per day [mg /day] for participants taking non-enzyme-inducing antiepileptic drug [non-EIAED] or 16 mg/day for participants taking EIAED) when given as an adjunctive therapy in participants ranging from 1 month to less than 4 years of age with epilepsy. The Pretreatment Phase will last up to 2 weeks, during which participants will be assessed for their eligibility to participate in the study. The Treatment Phase will consist of 3 periods: Titration (12 [for participants taking non-EIAED] to 16 weeks [for participants taking EIAED]), Maintenance (4 weeks), and Follow-Up (4 weeks; only for those participants who complete the Maintenance Period but do not continue into the Extension Phase and those participants who discontinue study participation). Extension Phase: The Extension Phase will consist of 2 periods: Maintenance (32 weeks [for participants taking EIAED]; 36 weeks [for participants taking non-EIAED]) and Follow-Up (4 weeks).
The maximum total duration of treatment for each participant will be 52 weeks and the maximum total duration of the study for each participant will be 58 weeks (2 weeks Pretreatment+52 weeks of treatment+4 weeks Follow-up).
Conditions Module
Conditions
Epilepsy
Keywords
epilepsy
refractory partial seizures
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
26Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Perampanel up to 12 or 16 mg/day
Experimental
Pediatric participants, ranging from 1 month to less than 4 years of age, will receive perampanel oral suspension once a day in titration period starting at Week 0 at a dose of 0.50 mg per day (mg/day) titrated up to 4 mg/day (for participants taking non-EIAED) or up to 8 mg/day (for participants taking EIAED). Depending on participants clinical response, tolerability and investigator's decision, dose can be up titrated to 6 mg/day (for participants taking non-EIAED) and up titrated to 8 mg/day (for participants taking EIAED). Dose titration must not exceed 12 mg/day (non-EIAED) and 16 mg/day (EIAED). Participants will continue taking the perampanel oral suspension at dose level achieved at end of titration period through maintenance period of core study and maintenance period of extension phase (Up to Week 52).
Drug: perampanel
Interventions
Name
Type
Description
Arm Group Labels
Other Names
perampanel
Drug
oral suspension.
Perampanel up to 12 or 16 mg/day
E2007
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose Normalized Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants
Dose normalized AUCtau,ss was calculated as AUCtau,ss/maintenance dose, where AUCtau,ss is the area under the curve during a dosing interval (tau, 24 hours) at steady state calculated using population pharmacokinetic (PK) model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated liquid chromatography mass spectrometry (LC MS/MS) analytical method.
Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4)
Dose Normalized Maximum (Peak) Steady-state Concentration (Cmax,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants
Dose normalized Cmax,ss was calculated as Cmax,ss/maintenance dose, where Cmax,ss is the maximum (peak) steady-state concentration calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4)
Dose Normalized Average Steady-state Drug Concentration (Css,Av) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants
Dose normalized Css,Av was calculated as Css,Av/maintenance dose. Css,Av of perampanel was calculated as the ratio of area under the curve (AUC)/tau, (tau = 24 hours for perampanel) using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
Secondary Outcomes
Measure
Description
Time Frame
Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAE was an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline); or re-emerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment; or worsened in severity during treatment relative to the pretreatment state, when AE was continuous. SAE was any untoward medical occurrence that at any dose: Resulted in death; was life-threatening (meaning participant was at an immediate risk of death from AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); Required inpatient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect (in child of a participant who was exposed to the study drug).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female, from 1 month to less than 4 years of age (and of at least 36 weeks gestational age) at the time of consent
Have a minimum weight of 4 kilograms (kg) (8.8 pounds [lb])
Have a diagnosis of epilepsy with any type of seizure according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures (1981). Diagnosis should have been established at least 2 weeks (≤6 months of age) or 4 weeks (>6 months of age) before Visit 1, by clinical history and an electroencephalogram (EEG) that is consistent with epilepsy; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (i.e., clinical history)
Have had brain imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) before Visit 1 that ruled out a progressive cause of epilepsy
Have had 1 or more seizure(s) before Visit 1
Currently being treated with a stable dose (i.e., unchanged for at least 5 half-lives) of 1 to a maximum of 4 antiepileptic drugs (AEDs) (at least 6, but not more than 8, in the age group of 1 to less than 24 months, and up to 13 subjects in the age group of 2 to less than 4 years, will be taking 1 EIAEDs [that is, carbamazepine (CBZ), oxcarbazepine (OXC), phenytoin (PHT), or eslicarbazepine (ESL)] out of the maximum of 4 AEDs. The remaining participants cannot be taking any EIAEDs).
Have been on their current concomitant AED(s) with a stable dose for at least 2 weeks or 5 half-lives, whichever is longer, before Visit 1
Must have discontinued all restricted medications (example, medications known to be inducers of cytochrome P450 3A) at least 2 weeks or 5 half-lives (whichever is longer) before Visit 1
If entering the Extension Phase, must have completed the last visit of the Maintenance Period of the Core Study
Exclusion Criteria:
Have a history of status epilepticus that required hospitalization during the 3 months before Visit 1
Have seizures due to treatable medical conditions, such as those arising due to metabolic disturbances, toxic exposure, or an active infection
Have epilepsy secondary to progressive central nervous system (CNS) disease or any other progressive neurodegenerative disease, including tumors
Have had epilepsy surgery within 1 year of Visit 1
Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1
Used intermittent rescue benzodiazepines (i.e., 1 to 2 doses over a 24-hour period considered one-time rescue) 2 or more times in the 2 weeks before Visit 1
Current use of felbamate, or any evidence of ongoing hepatic or bone marrow dysfunction associated with prior felbamate treatment. (Prior use of felbamate must be discontinued at least 8 weeks before Visit 1.)
Current use of vigabatrin or any evidence of clinically significant vision abnormality associated with prior vigabatrin treatment. (Prior use of vigabatrin must be discontinued at least 2 weeks before Visit 1.)
Are on ketogenic diet regimen that has not been stable for at least 4 weeks before Visit 1
Concomitant use of other drugs known to influence the CNS, (other than AEDs for epilepsy), where the dose has not been stabilized for at least 5 half-lives or 2 weeks, whichever is longer, before Visit 1
Have any concomitant illnesses/co-morbidities that could severely affect the participant's safety or study conduct
Have evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or study conduct
Have clinically significant laboratory abnormalities or any clinically acute or chronic disease
Have evidence of significant active hepatic disease. Stable elevation of liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) due to concomitant medication(s), will be allowed if they are less than 3 times the upper limit of normal (ULN)
Have clinical evidence of significant active hematological disease; white blood cell (WBC) count ≤2500/ microliter (μL) (2.50 x 10^9/Liter [L]) or an absolute neutrophil count ≤1000/μL (1.00 x 10^9/L)
Have conditions that may interfere with their participation in the study and/or with the PK of study drug
Have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer
Have recently (within 30 days before Visit 1) been exposed to perampanel in a clinical study or by prescription, and/or previous discontinuation from perampanel treatment due to adverse events related to perampanel
Have a clinically significant ECG abnormality, including prolonged corrected QT interval (QTc) defined as >450 milliseconds (msec)
Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (e.g., Stevens-Johnson syndrome), hematological, or organ toxicity reactions
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
1 Month
Maximum Age
4 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Children's Hospital Los Angeles
Los Angeles
California
90027
United States
David Geffen School of Medicine at UCLA
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 26 participants were screened and enrolled, of which 5 were screen failure and 21 participants received the study treatment.
Recruitment Details
Participants took part in the study at 8 investigative sites in the United States and Latvia from 20 February 2017 to 25 April 2023.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from greater than or equal to (>=) 1 month to less than or equal to (<=) 6 months received perampanel 0.5 milligrams (mg), oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 milligram per day (mg/day) (for participants who are not taking any EIAED]), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. All participants who completed Core Phase, entered Extension Phase, and continued their optimal perampanel dose in extension phase for up to Week 52. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants, and total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Periods
Title
Milestones
Reasons Not Completed
Core Phase (Up to 20 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 9, 2020
Feb 8, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Czechia
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4)
Dose Normalized Minimum Observed Steady State Plasma Concentration (Cmin,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants
Dose normalized Cmin,ss was calculated as Cmin,ss/maintenance dose, where Cmin,ss is the minimum observed steady state plasma concentration calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4)
Dose Normalized AUCtau,ss of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants
Dose normalized AUCtau,ss was calculated as AUCtau,ss/maintenance dose, where AUCtau,ss is the area under the curve during a dosing interval (tau, 24 hours) at steady state calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
Maintenance Period of the Core Phase- Days 127 and 141: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 127 and 141: Pre-dose, 1-5 hours post-dose (Cohort 4)
Dose Normalized Cmax,ss of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants
Dose normalized Cmax,ss was calculated as Cmax,ss/maintenance dose, where Cmax,ss is the maximum (peak) steady-state concentration calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
Maintenance Period of the Core Phase- Days 127 and 141: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 127 and 141: Pre-dose, 1-5 hours post-dose (Cohort 4)
Dose Normalized Css,Av of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants
Dose normalized Css,Av was calculated as Css,Av/maintenance dose. Css,Av of perampanel was calculated as the ratio of area under the curve (AUC)/tau, (tau = 24 hours for perampanel) using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
Maintenance Period of the Core Phase- Days 127 and 141: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 127 and 141: Pre-dose, 1-5 hours post-dose (Cohort 4)
Dose Normalized Cmin,ss of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants
Dose normalized Cmin,ss was calculated as Cmin,ss/maintenance dose, where Cmin,ss is the minimum observed steady state plasma concentration calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
Maintenance Period of the Core Phase- Days 127 and 141: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 127 and 141: Pre-dose, 1-5 hours post-dose (Cohort 4)
Core Phase: From the first dose of study drug up to 4 weeks of follow up after the last dose in Core Phase (up to Week 24); Extension Phase: From end of Core Phase treatment up to 4 weeks of follow up after the last dose in Extension Phase (up to Week 56)
Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, and Platelets
Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were expressed as 10^9 cells per liter (/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameter: Erythrocytes
Erythrocytes was expressed as 10^12 cells/L. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameter: Hemoglobin
Hemoglobin was expressed as grams per liter (g/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase
Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were expressed as units per liter (U/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameter: Bilirubin
Bilirubin was expressed as micromoles per liter (mcmol/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen
Calcium, chloride, cholesterol, glucose, phosphate, potassium, sodium, triglycerides, urea nitrogen were expressed as millimoles per liter (mmol/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Creatinine, Direct Bilirubin, Urate
Creatinine, direct bilirubin, urate were expressed as micromoles per liter (mcmol/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Albumin, Globulin, Protein
Albumin, globulin, protein were expressed as g/L. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured after the participant sitting or supine, for 5 minutes. SBP and DBP were expressed as millimeter of mercury (mmHg). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameter: Pulse Rate
Pulse rate measured after the participant sitting or supine, for 5 minutes and was expressed in beats per minute (beats/min). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameter: Respiratory Rate
Respiratory rate was the number of breaths taken per minute, measured at rest. Respiratory rate was expressed as breaths per minute (breaths/min). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameter: Body Temperature
Body temperature was expressed as degree centigrade. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Height
Height was expressed as centimeters. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Weight
Weight was expressed as kilograms. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Head Circumference
Head circumference was expressed as centimeters. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core and Extension Phase: Mean Change From Baseline in ECG Parameters: Single Beat Heart Rate-corrected QT Interval (QTcB), QT Interval Corrected According to the Formula of Fridericia (QTcF), PR and QT Intervals, QRS Duration, and Aggregate RR Interval
QTc: time from beginning of QRS complex to end of T wave, corrected for heart rate. QT interval: time from ECG Q wave to end of T wave corresponding to electrical systole. QRS interval: time from ECG Q wave to end of S wave, corresponding to ventricle depolarization. PR interval: time between beginning of P wave and start of QRS interval, corresponding to end of atrial depolarization and onset of ventricular depolarization. RR interval: time elapsed between two successive R waves of QRS signal. Single beat QTcB, QTcF, PR and QT Interval, QRS duration and aggregate RR interval were expressed as millisecond (msec). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in ECG Parameter: ECG Ventricular Rate
Ventricular rate is determined by dividing 60 by the mean RR interval of the ECG in seconds (mean time between QRS complexes) to get beats per minute. ECG ventricular rate was expressed as beats/min. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Thyroid Stimulating Hormone (TSH): Thyrotropin
Thyrotropin was expressed as milli-international units per liter (mIU/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Insulin-like Growth Factor 1 (IGF-1)
IGF-1 was expressed as millimoles per liter*10^-6 (mmol/L*10^-6). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Core Phase and Extension Phase: Mean Change From Baseline in Free Thyroxine, and Free Triiodothyronine
Free thyroxine, and free triiodothyronine were expressed as picomoles per liter (pmol/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
Los Angeles
California
90095-1752
United States
NW FL Clinical Research Group, LL-ClinEdge- PPDS
Gulf Breeze
Florida
32561
United States
Axcess Medical Research
Loxahatchee Groves
Florida
33470
United States
Pediatric Neurology PA
Orlando
Florida
32819
United States
Pediatric Epilepsy And Neurology Specialists
Tampa
Florida
33609
United States
Children's Healthcare of Atlanta
Atlanta
Georgia
30329
United States
Augusta University
Augusta
Georgia
30912
United States
Carle Foundation Hospital
Urbana
Illinois
61801
United States
University of Kentucky
Lexington
Kentucky
40536-0284
United States
Children's Mercy Hospital
Kansas City
Missouri
64108-4619
United States
Children's Hospital at Saint Peter's University Hospital
New Brunswick
New Jersey
08901
United States
Duke University Medical Center, Children's Health Center
Durham
North Carolina
27710
United States
Atrium Health Wake Forest Baptist Medical Center PPDS
Winston-Salem
North Carolina
27157
United States
Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
19104
United States
Child Neurology Consultants of Austin
Austin
Texas
78749
United States
Road Runner Research, Ltd
San Antonio
Texas
78249
United States
Children's Clinical University Hospital
Riga
LV-1004
Latvia
FG001
Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from greater than (>) 6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. All participants who completed Core Phase, entered Extension Phase, and continued their optimal perampanel dose in extension phase for up to Week 52. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants, and total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
FG002
Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to less than (<) 24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. All participants who completed Core Phase, entered Extension Phase, and continued their optimal perampanel dose in extension phase for up to Week 52. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants, and total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
FG003
Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. All participants who completed Core Phase, entered Extension Phase, and continued their optimal perampanel dose in extension phase for up to Week 52. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants, and total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
FG0004 subjects
FG0015 subjects
FG0029 subjects
FG0033 subjects
Participants Who Did Not Take EIAED
FG0004 subjects
FG0013 subjects
FG0025 subjects
FG0031 subjects
Participants Who Took EIAED
FG0000 subjects
FG0012 subjects
FG0024 subjects
FG0032 subjects
COMPLETED
FG0004 subjects
FG0015 subjects
FG0028 subjects
FG0031 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Inadequate Therapeutic Effect
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Extension Phase (Up to 36 Weeks)
Type
Comment
Milestone Data
STARTED
FG0004 subjectsAll participants who completed core phase entered extension phase.
FG0015 subjectsAll participants who completed core phase entered extension phase.
FG0028 subjectsAll participants who completed core phase entered extension phase.
FG0031 subjectsAll participants who completed core phase entered extension phase.
COMPLETED
FG0004 subjects
FG0015 subjects
FG0026 subjects
FG0031 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
The Safety Analysis Set (SAS) was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. All participants who completed Core Phase, entered Extension Phase, and continued their optimal perampanel dose in extension phase for up to Week 52. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants, and total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
BG001
Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. All participants who completed Core Phase, entered Extension Phase, and continued their optimal perampanel dose in extension phase for up to Week 52. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants, and total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
BG002
Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. All participants who completed Core Phase, entered Extension Phase, and continued their optimal perampanel dose in extension phase for up to Week 52. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants, and total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
BG003
Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. All participants who completed Core Phase, entered Extension Phase, and continued their optimal perampanel dose in extension phase for up to Week 52. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants, and total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0015
BG0029
BG0033
BG00421
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
months
Title
Denominators
Categories
Title
Measurements
BG0005.5± 0.58
BG00110.2± 0.84
BG00218.8± 3.73
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAE was an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline); or re-emerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment; or worsened in severity during treatment relative to the pretreatment state, when AE was continuous. SAE was any untoward medical occurrence that at any dose: Resulted in death; was life-threatening (meaning participant was at an immediate risk of death from AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); Required inpatient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect (in child of a participant who was exposed to the study drug).
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Posted
Count of Participants
Participants
Core Phase: From the first dose of study drug up to 4 weeks of follow up after the last dose in Core Phase (up to Week 24); Extension Phase: From end of Core Phase treatment up to 4 weeks of follow up after the last dose in Extension Phase (up to Week 56)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG003
Title
Denominators
Categories
Participants with TEAEs
Title
Measurements
OG0003
OG0015
OG0029
OG003
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, and Platelets
Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were expressed as 10^9 cells per liter (/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM and "number analyzed" signifies participants who were evaluable for specified categories.
Posted
Mean
Standard Deviation
10^9 cells/L
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameter: Erythrocytes
Erythrocytes was expressed as 10^12 cells/L. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
10^12 cells/L
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameter: Hemoglobin
Hemoglobin was expressed as grams per liter (g/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
g/L
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase
Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were expressed as units per liter (U/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
U/L
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameter: Bilirubin
Bilirubin was expressed as micromoles per liter (mcmol/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
mcmol/L
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen
Calcium, chloride, cholesterol, glucose, phosphate, potassium, sodium, triglycerides, urea nitrogen were expressed as millimoles per liter (mmol/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM and "number analyzed" signifies participants who were evaluable for specified categories.
Posted
Mean
Standard Deviation
mmol/L
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Creatinine, Direct Bilirubin, Urate
Creatinine, direct bilirubin, urate were expressed as micromoles per liter (mcmol/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
mcmol/L
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Albumin, Globulin, Protein
Albumin, globulin, protein were expressed as g/L. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
g/L
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured after the participant sitting or supine, for 5 minutes. SBP and DBP were expressed as millimeter of mercury (mmHg). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
mmHg
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameter: Pulse Rate
Pulse rate measured after the participant sitting or supine, for 5 minutes and was expressed in beats per minute (beats/min). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Posted
Mean
Standard Deviation
beats/min
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameter: Respiratory Rate
Respiratory rate was the number of breaths taken per minute, measured at rest. Respiratory rate was expressed as breaths per minute (breaths/min). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
breaths/min
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameter: Body Temperature
Body temperature was expressed as degree centigrade. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
degree centigrade
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Height
Height was expressed as centimeters. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
centimeters
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Weight
Weight was expressed as kilograms. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Posted
Mean
Standard Deviation
kilograms
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Head Circumference
Head circumference was expressed as centimeters. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
centimeters
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core and Extension Phase: Mean Change From Baseline in ECG Parameters: Single Beat Heart Rate-corrected QT Interval (QTcB), QT Interval Corrected According to the Formula of Fridericia (QTcF), PR and QT Intervals, QRS Duration, and Aggregate RR Interval
QTc: time from beginning of QRS complex to end of T wave, corrected for heart rate. QT interval: time from ECG Q wave to end of T wave corresponding to electrical systole. QRS interval: time from ECG Q wave to end of S wave, corresponding to ventricle depolarization. PR interval: time between beginning of P wave and start of QRS interval, corresponding to end of atrial depolarization and onset of ventricular depolarization. RR interval: time elapsed between two successive R waves of QRS signal. Single beat QTcB, QTcF, PR and QT Interval, QRS duration and aggregate RR interval were expressed as millisecond (msec). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM and "number analyzed" signifies participants who were evaluable for specified categories.
Posted
Mean
Standard Deviation
msec
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in ECG Parameter: ECG Ventricular Rate
Ventricular rate is determined by dividing 60 by the mean RR interval of the ECG in seconds (mean time between QRS complexes) to get beats per minute. ECG ventricular rate was expressed as beats/min. Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
beats/min
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Thyroid Stimulating Hormone (TSH): Thyrotropin
Thyrotropin was expressed as milli-international units per liter (mIU/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
mIU/L
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Insulin-like Growth Factor 1 (IGF-1)
IGF-1 was expressed as millimoles per liter*10^-6 (mmol/L*10^-6). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameter was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
mmol/L*10^-6
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Secondary
Core Phase and Extension Phase: Mean Change From Baseline in Free Thyroxine, and Free Triiodothyronine
Free thyroxine, and free triiodothyronine were expressed as picomoles per liter (pmol/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported.
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
pmol/L
Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
Primary
Dose Normalized Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants
Dose normalized AUCtau,ss was calculated as AUCtau,ss/maintenance dose, where AUCtau,ss is the area under the curve during a dosing interval (tau, 24 hours) at steady state calculated using population pharmacokinetic (PK) model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated liquid chromatography mass spectrometry (LC MS/MS) analytical method.
The PK Analysis Set was the group of participants with at least 1 PK assessment of perampanel during the Maintenance Period (Core Phase) with a documented dosing history. Here, "overall number of participants analyzed" signifies participants who were evaluable for this Outcome Measure (OM).
Posted
Mean
Standard Deviation
nanogram*hour per milliliter (ng*h/mL)
Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel (Non-EIAED)
Participants of age range from >=1 to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Primary
Dose Normalized Maximum (Peak) Steady-state Concentration (Cmax,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants
Dose normalized Cmax,ss was calculated as Cmax,ss/maintenance dose, where Cmax,ss is the maximum (peak) steady-state concentration calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
The PK Analysis Set was the group of participants with at least 1 PK assessment of perampanel during the Maintenance Period (Core Phase) with a documented dosing history. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/mL)
Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel (Non-EIAED)
Participants of age range from >=1 to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Primary
Dose Normalized Average Steady-state Drug Concentration (Css,Av) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants
Dose normalized Css,Av was calculated as Css,Av/maintenance dose. Css,Av of perampanel was calculated as the ratio of area under the curve (AUC)/tau, (tau = 24 hours for perampanel) using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
The PK Analysis Set was the group of participants with at least 1 PK assessment of perampanel during the Maintenance Period (Core Phase) with a documented dosing history. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
ng/mL
Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel (Non-EIAED)
Participants of age range from >=1 to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Primary
Dose Normalized Minimum Observed Steady State Plasma Concentration (Cmin,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants
Dose normalized Cmin,ss was calculated as Cmin,ss/maintenance dose, where Cmin,ss is the minimum observed steady state plasma concentration calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
The PK Analysis Set was the group of participants with at least 1 PK assessment of perampanel during the Maintenance Period (Core Phase) with a documented dosing history. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
ng/mL
Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel (Non-EIAED)
Participants of age range from >=1 to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Primary
Dose Normalized AUCtau,ss of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants
Dose normalized AUCtau,ss was calculated as AUCtau,ss/maintenance dose, where AUCtau,ss is the area under the curve during a dosing interval (tau, 24 hours) at steady state calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
The PK Analysis Set was the group of participants with at least 1 PK assessment of perampanel during the Maintenance Period (Core Phase) with a documented dosing history. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
ng*h/mL
Maintenance Period of the Core Phase- Days 127 and 141: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 127 and 141: Pre-dose, 1-5 hours post-dose (Cohort 4)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel (EIAED)
Participants of age range from >=1 to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Primary
Dose Normalized Cmax,ss of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants
Dose normalized Cmax,ss was calculated as Cmax,ss/maintenance dose, where Cmax,ss is the maximum (peak) steady-state concentration calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
The PK Analysis Set was the group of participants with at least 1 PK assessment of perampanel during the Maintenance Period (Core Phase) with a documented dosing history. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
ng/mL
Maintenance Period of the Core Phase- Days 127 and 141: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 127 and 141: Pre-dose, 1-5 hours post-dose (Cohort 4)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel (EIAED)
Participants of age range from >=1 to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Primary
Dose Normalized Css,Av of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants
Dose normalized Css,Av was calculated as Css,Av/maintenance dose. Css,Av of perampanel was calculated as the ratio of area under the curve (AUC)/tau, (tau = 24 hours for perampanel) using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
The PK Analysis Set was the group of participants with at least 1 PK assessment of perampanel during the Maintenance Period (Core Phase) with a documented dosing history. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
ng/mL
Maintenance Period of the Core Phase- Days 127 and 141: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 127 and 141: Pre-dose, 1-5 hours post-dose (Cohort 4)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel (EIAED)
Participants of age range from >=1 to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Primary
Dose Normalized Cmin,ss of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants
Dose normalized Cmin,ss was calculated as Cmin,ss/maintenance dose, where Cmin,ss is the minimum observed steady state plasma concentration calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method.
The PK Analysis Set was the group of participants with at least 1 PK assessment of perampanel during the Maintenance Period (Core Phase) with a documented dosing history. Here, "overall number of participants analyzed" signifies participants who were evaluable for this OM.
Posted
Mean
Standard Deviation
ng/mL
Maintenance Period of the Core Phase- Days 127 and 141: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 127 and 141: Pre-dose, 1-5 hours post-dose (Cohort 4)
ID
Title
Description
OG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel (EIAED)
Participants of age range from >=1 to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Time Frame
Core Phase: From the first dose of study drug up to 4 weeks of follow up after the last dose in Core Phase (up to Week 24); Extension Phase: From end of Core Phase treatment up to 4 weeks of follow up after the last dose in Extension Phase (up to Week 56)
Description
The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
0
4
2
4
2
4
EG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
0
5
1
5
5
5
EG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
0
9
2
9
9
9
EG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
0
3
1
3
2
3
EG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
0
4
3
4
2
4
EG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
0
5
1
5
5
5
EG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
0
8
3
8
8
8
EG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
3
OG0044
OG0055
OG0068
OG0071
3
OG0044
OG0055
OG0068
OG0071
Participants with SAEs
Title
Measurements
OG0002
OG0011
OG0022
OG0031
OG0043
OG0051
OG0063
OG0070
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0003
OG0015
OG0027
OG0032
OG0043
OG0055
OG0066
OG0071
Title
Denominators
Categories
Change in Basophils
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
Title
Measurements
OG0000.03± 0.058
OG001-0.02± 0.110
OG002-0.06± 0.151
OG003
Change in Eosinophils
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
Change in Leukocytes
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
Change in Lymphocytes
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
Change in Monocytes
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
Change in Neutrophils
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
Change in Platelets
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0032
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0003
OG0015
OG0027
OG0032
OG0043
OG0055
OG0066
OG0071
Title
Denominators
Categories
Title
Measurements
OG0000.44± 0.576
OG0010.16± 0.501
OG0020.10± 0.155
OG003-0.10± 0.283
OG0040.27± 0.329
OG0050.39± 0.919
OG006-0.14± 0.396
OG007-0.03± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0003
OG0015
OG0027
OG0032
OG0043
OG0055
OG0066
OG0071
Title
Denominators
Categories
Title
Measurements
OG00014.00± 18.000
OG0015.20± 8.899
OG0023.14± 3.237
OG003-0.25± 3.889
OG00410.00± 8.888
OG00512.80± 20.945
OG006-1.33± 13.808
OG007-6.50± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0004
OG0015
OG0027
OG0032
OG0044
OG0055
OG0067
OG0071
Title
Denominators
Categories
Change in Alanine Aminotransferase
Title
Measurements
OG000-2.25± 7.932
OG001-16.00± 27.803
OG002-13.71± 33.265
OG0036.00± 15.556
OG00436.50± 90.820
OG005-16.00± 27.313
OG006-11.43± 37.228
OG007-4.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
Change in Alkaline Phosphatase
Title
Measurements
OG00043.50± 115.610
OG001266.00± 652.320
OG00223.86± 21.162
OG003
Change in Aspartate Aminotransferase
Title
Measurements
OG000-2.00± 2.449
OG001-12.20± 21.993
OG002-6.57± 16.009
OG003
Change in Gamma Glutamyl Transferase
Title
Measurements
OG00012.50± 87.577
OG001-3.00± 3.536
OG002-15.71± 31.653
OG003
Change in Lactate Dehydrogenase
Title
Measurements
OG000-6.00± 50.721
OG001-32.60± 54.574
OG002-14.43± 28.425
OG003
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0004
OG0015
OG0027
OG0032
OG0044
OG0055
OG0067
OG0071
Title
Denominators
Categories
Title
Measurements
OG000-0.30± 0.600
OG0010.64± 2.057
OG002-0.46± 1.555
OG0030.70± 0.990
OG004-0.10± 0.200
OG0051.24± 2.414
OG006-0.57± 1.093
OG0070.90± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0004
OG0015
OG0027
OG0032
OG0044
OG0055
OG0067
OG0071
Title
Denominators
Categories
Change in Calcium
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0071
Title
Measurements
OG000-0.08± 0.147
OG0010.02± 0.095
OG002-0.00± 0.098
OG003
Change in Chloride
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
Change in Cholesterol
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
Change in Glucose
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0030
Change in Phosphate
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0032
Change in Potassium
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
Change in Sodium
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
Change in Triglycerides
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
Change in Urea Nitrogen
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0032
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0004
OG0015
OG0027
OG0032
OG0044
OG0055
OG0067
OG0071
Title
Denominators
Categories
Change in Creatinine
Title
Measurements
OG0002.25± 4.505
OG0011.80± 4.024
OG002-1.28± 3.402
OG0034.51± 6.357
OG0046.51± 8.187
OG0053.61± 4.929
OG0061.29± 3.400
OG0079.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
Change in Direct Bilirubin
Title
Measurements
OG0000.00± 0.000
OG0010.08± 0.183
OG0020.00± 0.000
OG003
Change in Urate
Title
Measurements
OG0000.00± 0.024
OG001-0.02± 0.064
OG002-0.02± 0.032
OG003
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0004
OG0015
OG0027
OG0032
OG0044
OG0055
OG0067
OG0071
Title
Denominators
Categories
Change in Albumin
Title
Measurements
OG0000.50± 1.291
OG0012.00± 4.183
OG002-0.29± 2.059
OG003-1.00± 4.243
OG0042.00± 3.266
OG0055.60± 7.335
OG006-0.29± 2.870
OG0072.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
Change in Globulin
Title
Measurements
OG0002.50± 6.455
OG001-2.20± 3.114
OG0020.71± 1.496
OG003
Change in Protein
Title
Measurements
OG0003.00± 5.657
OG001-0.20± 2.588
OG0020.43± 3.047
OG003
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0003
OG0015
OG0029
OG0033
OG0043
OG0055
OG0068
OG0071
Title
Denominators
Categories
Change in SBP
Title
Measurements
OG000-1.00± 26.211
OG0010.60± 6.066
OG0020.33± 19.780
OG00310.33± 4.726
OG00427.00± 30.199
OG0054.00± 5.477
OG00610.63± 20.333
OG00716.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
Change in DBP
Title
Measurements
OG000-5.33± 3.786
OG0014.40± 5.857
OG002-0.89± 10.659
OG003
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG0033
OG0044
OG0055
OG0068
OG0071
Title
Denominators
Categories
Title
Measurements
OG0005.25± 16.112
OG001-4.40± 7.537
OG002-14.89± 14.675
OG003-21.67± 21.127
OG004-9.25± 14.773
OG005-15.80± 11.670
OG006-13.75± 9.543
OG007-26.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0003
OG0015
OG0029
OG0033
OG0043
OG0055
OG0068
OG0071
Title
Denominators
Categories
Title
Measurements
OG000-5.33± 6.110
OG001-3.00± 4.183
OG002-4.78± 8.243
OG003-5.33± 2.309
OG004-4.33± 7.506
OG005-4.80± 5.541
OG006-3.88± 7.415
OG0076.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0003
OG0015
OG0029
OG0033
OG0043
OG0055
OG0068
OG0071
Title
Denominators
Categories
Title
Measurements
OG0000.10± 0.265
OG001-0.02± 0.130
OG0020.02± 0.199
OG0030.13± 0.153
OG0040.47± 0.702
OG0050.02± 0.045
OG006-0.16± 0.311
OG007-0.20± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG0032
OG0044
OG0055
OG0068
OG0071
Title
Denominators
Categories
Title
Measurements
OG0004.76± 2.197
OG0015.20± 2.361
OG0025.06± 1.429
OG0033.63± 1.237
OG00417.65± 3.643
OG00512.78± 2.548
OG00610.24± 1.849
OG0076.50± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG0033
OG0044
OG0055
OG0068
OG0071
Title
Denominators
Categories
Title
Measurements
OG0001.88± 0.377
OG0011.20± 1.065
OG0021.01± 1.134
OG0030.77± 0.153
OG0043.88± 2.081
OG0053.24± 1.356
OG0062.88± 1.792
OG0070.90± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG0032
OG0044
OG0055
OG0068
OG0071
Title
Denominators
Categories
Title
Measurements
OG0001.87± 1.231
OG0011.50± 1.061
OG0021.14± 1.927
OG003-0.15± 0.495
OG0044.02± 0.846
OG0052.50± 0.791
OG0062.36± 1.537
OG0070.50± NAStandard Deviation could not be calculated as only one participant was available for analysis.
Participants of age range from >=1 month to <=6 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG0033
OG0044
OG0055
OG0067
OG0071
Title
Denominators
Categories
Change in Single Beat QTcB Interval
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0028
ParticipantsOG0033
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
Title
Measurements
OG000-9.0± 24.06
OG001-7.0± 26.29
OG002-3.8± 33.86
OG003
Change in Single Beat QTcF Interval
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0028
ParticipantsOG0033
Change in Single Beat PR Interval
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0028
ParticipantsOG0033
Change in Single Beat QRS Duration
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0028
ParticipantsOG0033
Change in Aggregate RR Interval
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0033
Change in Single Beat QT Interval
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0028
ParticipantsOG0033
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG0033
OG0044
OG0055
OG0067
OG0071
Title
Denominators
Categories
Title
Measurements
OG000-7.5± 9.04
OG0018.6± 7.37
OG002-12.2± 11.39
OG00318.7± 22.85
OG004-36.25± 4.272
OG005-4.40± 15.437
OG006-3.14± 17.837
OG00750.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0003
OG0013
OG0025
OG0031
OG0044
OG0055
OG0066
OG0071
Title
Denominators
Categories
Title
Measurements
OG0001.12± 1.242
OG001-1.02± 0.279
OG0021.33± 1.283
OG003-0.90± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG0040.05± 0.590
OG005-0.89± 1.405
OG006-0.08± 1.026
OG007-0.35± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0031
OG0043
OG0054
OG0067
OG0071
Title
Denominators
Categories
Title
Measurements
OG000-2.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG0017.00± 3.606
OG0023.60± 6.066
OG0031.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG0046.00± 0.000
OG0054.75± 5.439
OG0066.29± 9.160
OG007-1.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to a maximum of 12 mg/day (for participants who are not taking any EIAED), or titrated up to a maximum of 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants and up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose up to 12 mg/day (for non-EIAED participants) or 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase. The total treatment duration of Core Phase was up to 16 weeks for non-EIAED participants or up to 20 weeks for EIAED participants.
OG004
Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel
Participants of age range from >=1 month to <=6 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG005
Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel
Participants of age range from >6 to <=12 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG006
Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel
Participants of age range from >12 to <24 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
OG007
Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel
Participants of age range from >=24 to <48 months who completed the Core Phase continued their optimal perampanel oral suspension, at the dose level achieved at the end of the Core Phase. The maximum total daily allowed dose for a non-EIAED participants was 12 mg and 16 mg for EIAED participants. The total treatment duration of Extension Phase was up to 36 weeks for non-EIAED participants and 32 weeks for EIAED participants.
Units
Counts
Participants
OG0003
OG0011
OG0025
OG0031
OG0044
OG0053
OG0065
OG0071
Title
Denominators
Categories
Change in Free Thyroxine
Title
Measurements
OG0000.90± 1.931
OG001-1.30± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG002-1.80± 1.147
OG003-3.90± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG0042.55± 1.021
OG0050.83± 1.443
OG0060.00± 0.919
OG007-3.90± NAStandard Deviation could not be calculated as only one participant was available for analysis.
Change in Free Triiodothyronine
Title
Measurements
OG000-0.40± 0.889
OG0010.60± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG0020.06± 0.885
OG003
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel (Non-EIAED)
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel (Non-EIAED)
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel (Non-EIAED)
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0031
Title
Denominators
Categories
Title
Measurements
OG0003840± 2280
OG0016110± 1490
OG0026030± 1940
OG0035810± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel (Non-EIAED)
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel (Non-EIAED)
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel (Non-EIAED)
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0031
Title
Denominators
Categories
Title
Measurements
OG000305± 73.1
OG001388± 68.4
OG002386± 103
OG003341± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel (Non-EIAED)
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel (Non-EIAED)
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel (Non-EIAED)
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0031
Title
Denominators
Categories
Title
Measurements
OG000160± 95
OG001255± 62.2
OG002251± 80.8
OG003242± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel (Non-EIAED)
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel (Non-EIAED)
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel (Non-EIAED)
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 12 mg/day (for participants who are not taking any EIAED). Dose titration was up to Week 12 for Non-EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 12 mg/day (for Non-EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0031
Title
Denominators
Categories
Title
Measurements
OG000114± 96.4
OG001203± 58.2
OG002199± 71
OG003203± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel (EIAED)
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel (EIAED)
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel (EIAED)
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Units
Counts
Participants
OG0000
OG0012
OG0023
OG0031
Title
Denominators
Categories
Title
Measurements
OG0015220± 3600
OG0023300± 1530
OG0032510± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel (EIAED)
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel (EIAED)
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel (EIAED)
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Units
Counts
Participants
OG0000
OG0012
OG0023
OG0031
Title
Denominators
Categories
Title
Measurements
OG001341± 151
OG002276± 81.8
OG003201± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel (EIAED)
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel (EIAED)
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel (EIAED)
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Units
Counts
Participants
OG0000
OG0012
OG0023
OG0031
Title
Denominators
Categories
Title
Measurements
OG001217± 150
OG002137± 63.8
OG003105± NAStandard Deviation could not be calculated as only one participant was available for analysis.
OG001
Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel (EIAED)
Participants of age range from >6 to <=12 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG002
Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel (EIAED)
Participants of age range from >12 to <24 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
OG003
Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel (EIAED)
Participants of age range from >=24 to <48 months received perampanel 0.5 mg, oral suspension, before bedtime during Week 0 and then dose up titrated to 16 mg/day (for participants who are taking any EIAED). Dose titration was up to Week 16 for EIAED participants to identify each participant's optimum dose during Core Phase. Participants then continued to take perampanel at optimal dose level 16 mg/day (for EIAED participants) as a maintenance dose for up to 4 weeks during Core Phase.
Units
Counts
Participants
OG0000
OG0012
OG0023
OG0031
Title
Denominators
Categories
Title
Measurements
OG001172± 145
OG00290.5± 53.4
OG00369.2± NAStandard Deviation could not be calculated as only one participant was available for analysis.
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
1 events
1 affected
3 at risk
EG0042 events2 affected4 at risk
EG0052 events1 affected5 at risk
EG0065 events2 affected8 at risk
EG0070 events0 affected1 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected1 at risk
2 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0054 events2 affected5 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0063 events2 affected8 at risk
EG0070 events0 affected1 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
2 events
2 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0063 events3 affected8 at risk
EG0072 events1 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected1 at risk
0.00
± 0.000
OG0040.03± 0.058
OG0050.04± 0.219
OG006-0.05± 0.122
OG0070.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
Title
Measurements
OG000-0.03± 0.115
OG001-0.00± 0.100
OG002-0.04± 0.513
OG003-0.15± 0.212
OG0040.10± 0.100
OG0050.02± 0.148
OG006-0.05± 0.399
OG0070.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
Title
Measurements
OG0001.73± 2.316
OG0011.26± 5.855
OG0021.10± 3.062
OG0032.82± 6.187
OG0042.43± 1.601
OG005-0.76± 4.558
OG006-1.08± 4.712
OG007-1.45± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
Title
Measurements
OG0001.00± 1.500
OG0010.62± 2.448
OG0020.54± 2.099
OG003-1.73± 0.813
OG0040.53± 0.757
OG005-0.24± 1.627
OG006-1.38± 2.555
OG007-1.75± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
Title
Measurements
OG000-0.13± 0.153
OG0010.10± 0.308
OG0020.10± 0.606
OG0030.33± 0.672
OG0040.10± 0.100
OG005-0.10± 0.292
OG006-0.02± 0.325
OG0070.25± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
Title
Measurements
OG0000.90± 0.781
OG0010.60± 3.820
OG0020.51± 1.975
OG0034.35± 6.435
OG0041.70± 0.954
OG005-0.46± 2.518
OG0060.38± 3.019
OG0070.10± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0042
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0071
Title
Measurements
OG000-44.00± 108.894
OG001-63.80± 192.587
OG00263.00± 167.127
OG003-22.50± 57.276
OG0047.50± 98.288
OG005-32.00± 280.306
OG00623.80± 147.041
OG007-85.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
-46.50
± 53.033
OG004-12.75± 97.072
OG005-32.40± 147.179
OG006-77.29± 205.368
OG007-58.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
0.50
± 3.536
OG00421.00± 58.980
OG005-13.20± 22.477
OG006-8.43± 19.569
OG0071.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
5.00
± 5.657
OG00450.00± 320.278
OG005-5.40± 4.336
OG006-23.71± 48.801
OG007-1.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
51.50
± 132.229
OG0041.00± 68.775
OG005-44.60± 49.863
OG006-17.29± 67.037
OG007-39.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
-0.01
± 0.014
OG004-0.05± 0.123
OG0050.05± 0.139
OG006-0.02± 0.103
OG007-0.04± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0071
Title
Measurements
OG000-0.25± 2.500
OG001-0.80± 1.304
OG002-1.71± 3.450
OG003-1.00± 2.828
OG0040.00± 2.160
OG005-2.60± 3.578
OG0060.43± 1.988
OG0071.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0071
Title
Measurements
OG0000.45± 0.191
OG0010.52± 1.102
OG002-0.02± 0.505
OG0030.58± 0.311
OG004-0.55± 0.583
OG0051.48± 1.369
OG0060.19± 0.578
OG0070.83± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0042
ParticipantsOG0054
ParticipantsOG0065
ParticipantsOG0070
Title
Measurements
OG000-0.42± 0.898
OG0010.78± 0.668
OG002-0.24± 1.450
OG0040.34± 1.096
OG0050.18± 0.249
OG006-0.07± 0.640
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0067
ParticipantsOG0071
Title
Measurements
OG000-0.22± 0.277
OG0010.11± 0.339
OG002-0.00± 0.154
OG003-0.31± 0.714
OG0040.05± 0.169
OG0050.16± 0.042
OG006-0.08± 0.145
OG0070.07± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0071
Title
Measurements
OG000-0.23± 0.222
OG0010.06± 0.167
OG0020.19± 0.652
OG0030.25± 0.212
OG004-0.10± 0.712
OG005-0.02± 0.669
OG0060.21± 0.285
OG007-0.60± NAStandard Deviation could not be calculated as only one participant was available for analysis.
Participants
OG004
4
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0071
Title
Measurements
OG0001.25± 2.986
OG0010.00± 2.236
OG002-1.86± 2.911
OG0034.00± 4.243
OG0040.50± 3.109
OG005-0.40± 2.408
OG0061.14± 0.690
OG007-2.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0071
Title
Measurements
OG0000.94± 0.619
OG001-0.50± 0.641
OG0020.27± 1.047
OG0030.44± 0.156
OG0040.54± 0.602
OG005-0.05± 0.910
OG006-0.09± 0.544
OG0070.05± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0071
Title
Measurements
OG0000.27± 0.791
OG0010.74± 1.440
OG002-0.97± 1.296
OG0030.18± 1.768
OG0041.69± 0.942
OG0050.89± 3.316
OG0060.61± 1.694
OG0070.36± NAStandard Deviation could not be calculated as only one participant was available for analysis.
0.00
± 0.000
OG0040.00± 0.000
OG0050.08± 0.183
OG0060.00± 0.000
OG0070.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
0.01
± 0.097
OG004-0.01± 0.054
OG0050.01± 0.086
OG006-0.00± 0.045
OG0070.04± NAStandard Deviation could not be calculated as only one participant was available for analysis.
-2.00
± 2.828
OG0047.25± 8.057
OG0050.20± 3.347
OG0063.43± 2.760
OG0073.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
-3.00
± 7.071
OG0049.25± 9.287
OG0055.80± 7.596
OG0063.14± 3.934
OG0075.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
8.67
± 6.429
OG00423.00± 20.298
OG0051.60± 5.941
OG0066.00± 9.885
OG0070.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
17.0
± 14.42
OG004-29.75± 27.476
OG005-5.60± 32.168
OG0064.33± 8.710
OG00758.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
Title
Measurements
OG000-4.5± 20.86
OG001-10.0± 21.99
OG0021.9± 29.95
OG0035.7± 8.62
OG004-8.25± 22.721
OG005-2.40± 36.115
OG0061.17± 9.347
OG00727.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
Title
Measurements
OG000-2.8± 4.57
OG001-2.8± 8.47
OG002-1.1± 16.66
OG003-10.3± 12.66
OG0043.00± 3.162
OG0053.80± 13.236
OG0062.50± 8.689
OG007-3.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
Title
Measurements
OG000-0.5± 5.45
OG001-0.2± 5.89
OG002-0.8± 3.20
OG003-6.0± 8.00
OG0043.75± 2.986
OG005-1.20± 6.181
OG006-1.67± 3.830
OG0071.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0071
Title
Measurements
OG00028.3± 35.36
OG001-30.4± 26.37
OG00260.7± 61.84
OG003-76.7± 77.36
OG004165.25± 31.127
OG00523.00± 72.087
OG00620.57± 81.506
OG007-178.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
Title
Measurements
OG0001.8± 17.23
OG001-13.8± 16.04
OG00210.6± 29.61
OG003-10.0± 18.33
OG00423.25± 14.569
OG0052.40± 41.374
OG006-3.17± 15.779
OG007-16.00± NAStandard Deviation could not be calculated as only one participant was available for analysis.
-4.30
± NA
Standard Deviation could not be calculated as only one participant was available for analysis.
OG0040.28± 1.250
OG0051.03± 0.611
OG006-0.16± 1.230
OG007-1.80± NAStandard Deviation could not be calculated as only one participant was available for analysis.