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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002167-16 | EudraCT Number |
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This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than [<] 12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic (PGTC) seizures.
This is a multicenter, open-label, single-arm study in children (age 4 to <12 years) with inadequately controlled POS or PGTC seizures. The study will consist of a Core Phase and two Extension Phases (Extension Phase A [for all countries in the study], and Extension Phase B [available for participants enrolled in Japan and in countries where an extended access program {EAP} cannot be implemented, after completion of Extension Phase A]). The Core Phase will consist of the following 2 phases: Pretreatment and Treatment Phase. The Pretreatment Phase, during which participants will be assessed for eligibility, will consist of up to a 4-weeks +/- 3 days Screening/Baseline Period. The Treatment Phase will consist of 3 periods: Titration Period (up to an 11-weeks: dose titration on the basis of individual clinical response and tolerability), Maintenance Period (up to a 12-weeks: continuation of perampanel oral suspension once daily at the dose level achieved at the end of the Titration Period), and Follow-up Period (up to 4-weeks +/- 7 days: only for those participants not entering into Extension Phase A or those who prematurely discontinue from the study). Extension Phase A will consist of up to 29-weeks Maintenance Period and up to 4-weeks +/- 7 days Follow-up Period after the last dose of perampanel only for participants who did not enter into Extension Phase B. All participants who complete all scheduled visits up to and including Visit 9 in the Treatment Phase will be eligible to participate in Extension Phase A of the study. During the Maintenance Period of Extension Phase A, all participants will continue with their optimal perampanel dose (that is, dose level that they complete on during the Core Phase). After completing Extension Phase A, participants in Japan and in countries where EAP cannot be implemented, participants will be eligible to participate in Extension Phase B. In Japan, treatment will continue as long as clinically appropriate according to the judgment of the investigator. However, treatment of participants in Extension B will be completed when the participant reaches 12 years of age or when perampanel is commercially available in Japan for treatment of POS in pediatric participants (4 to less than 12 years of age). In countries where an EAP cannot be implemented, participation in Extension B will continue as long as clinically appropriate according to the judgment of the investigator, until the participants reaches 12 years of age or perampanel oral suspension is commercially available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perampanel | Experimental | Perampanel 0.5 milligrams per milliliter (mg/mL) oral suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug | E2007 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) for Total Group of Participants - Core Phase and Extension Phase A of This Study | Baseline up to 4 weeks (follow up in Extension Phase A) after last dose of study drug in Extension Phase A at Week 52 (up to 56 weeks) | |
| Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study | Baseline up to 52 weeks | |
| Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study | Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) of greater than or equal to (>=) 20 or 40 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) >=10 or 20 mmHg; increase or decrease from baseline in pulse rate (number of heart beats per minute [bpm]) of >=15 or 30 bpm. Data for this outcome measure has been assessed and reported till Week 52. | Baseline up to 52 weeks |
| Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study | Baseline up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Model Predicted Percent Change in Average Seizure Frequency Over 28 Days During Maintenance Period in Core Phase of This Study From Baseline- Assessed as Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel (518 ng/mL) | Seizure frequency derived from information (seizure count and type) recorded in participant diary. Seizure frequency per 28 days was calculated as number of seizures divided by number of days in interval; multiplied by 28. Due to sparse pharmacokinetic (PK) sampling in study, data of endpoint was analyzed by pooling data from other Phase II and III studies of perampanel along with data of this current study, including participants with POS or PGTC. Only data for participants taking perampanel 8 mg/day (corresponding to Cav, ss of 518 ng/mL) were reported. Participants taking perampanel 12 mg/day in studies from which data were pooled, were not included in analysis for this measure. Here, ng/mL= nanogram per milliliter. Data for this measure was calculated through model prediction; reported as "percent change" with measure type as "number" and measure dispersion as "Not applicable, NA". |
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Inclusion Criteria:
Exclusion Criteria:
Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 International Units per liter [IU/L] or equivalent units of β-hCG or hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
Females of childbearing potential who:
Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before Visit 1
Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1
Have an unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified tests (example, significant suicide risk, including suicidal behavior and ideation within 6 months before Visit 1, current psychotic disorder, acute mania)
Any suicidal ideation with intent with or without a plan within 6 months before Visit 2 (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale [C-SSRS]) in participants aged 6 and above
Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however, those who have previously documented "failed" epilepsy surgery will be allowed
Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
Evidence of moderate or severe renal insufficiency as defined by estimated glomerular filtration rates (eGFRs) of 31 to <60 milliliters per minute (mL/min) and <30 mL/min, respectively
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)
Evidence of significant active hematological disease; white blood cell (WBC) count equal or less than (=<) 2500 per (/) microliter (µL) (2.50 1 constant [E]+09/liter [L]) or an absolute neutrophil count =<1000/µL (1.00 1E+09/L)
Clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as greater than (>) 450 milliseconds (msec)
Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
Multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (example, Stevens Johnson syndrome), hematological, or organ toxicity reactions.
Concomitant use of felbamate as an AED for <2 years or where the dose has not been stable for at least 8 weeks before Visit 1. Participants must not have a history of WBC count =<2500/µL, platelets below 100,000, liver function tests (LFTs) above 3 times the ULN, or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If participants received felbamate in the past, it must have been discontinued 8 weeks before Visit 1 to be eligible for study participation
Concomitant use of vigabatrin: participants who took vigabatrin in the past must be off vigabatrin for at least 5 months before Visit 1 and with documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in a visual perimetry test
Concomitant use of cannabinoids
Used benzodiazepines for epilepsy during which the dose has not been stable for >4 weeks prior to Visit 1. Benzodiazepines use as rescue medication for seizure control is allowed; however, intermittent use of benzodiazepines for any other indication (example, anxiety/sleep disorders) is prohibited
A VNS implanted <5 months before Visit 1 or changes in parameter <4 weeks before Visit 1 (or thereafter during the study)
On a ketogenic diet for which the diet is not a stable regimen for at least 4 weeks before Visit 1
History of or a concomitant medical condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study or compromise the participant's ability to safely complete the study
Have previously been exposed to perampanel in a clinical trial or by prescription for more than 2 months or discontinued for Adverse Events (AEs)
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
Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
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| Name | Affiliation | Role |
|---|---|---|
| Eisai Medical Information | Eisai Inc. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facility #1 | Little Rock | Arkansas | United States | |||
| Facility #1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33839450 | Derived | Trigg A, Brohan E, Cocks K, Jones A, Tahami Monfared AA, Chabot I, Meier G, Campbell R, Li H, Ngo LY. Health-related quality of life in pediatric patients with partial onset seizures or primary generalized tonic-clonic seizures receiving adjunctive perampanel. Epilepsy Behav. 2021 May;118:107938. doi: 10.1016/j.yebeh.2021.107938. Epub 2021 Apr 8. | |
| 31912493 |
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A total of 208 participants were screened; of which 28 were screen failures; 180 received study treatment in Core Phase. Of 146 participants who completed the Core Phase, 136 entered Extension Phase A. Of 122 who completed Extension Phase A, 42 received treatment in Extension B. Study has a Core Phase and two Extension Phases (Phase A and Phase B). In Extension Phase B only safety data was collected for participants who could not enroll in an extended access program (EAP).
Participants took part at 58 investigative sites in the United States, European Union and Asia Pacific from 16 November 2016 to 06 December 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Core Study + Extension Part A: Perampanel 0.5 mg/mL: POS | Core Phase: Participants with partial onset-seizures (POS) received perampanel 0.5 milligrams per milliliter (mg/mL) oral suspension titrated beyond 8 milligram per day (mg/day) up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any enzyme-inducing antiepileptic drug [EIAED]), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel once daily at optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed Core Phase, entered Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Phase (up to 23 Weeks) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2018 | Feb 5, 2020 |
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| Baseline, Week 23 |
| Overall Responder Probability For Non-Asian Participants With POS During Core Phase of This Study: Assessment Based on Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel | For this outcome measure, responders were those who experienced a 50 percent (%) or greater reduction in seizure frequency per 28 days from baseline. Due to the sparse PK sampling in this study, the data of this outcome measure were pooled with data from other Phase III studies of perampanel conducted in participants with POS. "AEDs not affecting PK" refers to AEDs not affecting PK of perampanel. Data for this outcome measure has been reported for only non-Asian participants with POS per age groups. Responder probability has been reported for Cav,ss of perampanel when given along with different antiepileptic drugs (AEDs). | Baseline up to 23 weeks |
| Overall Responder Probability For Participants With PGTC Seizures During Core Phase of This Study: Assessment Based on Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel | For this outcome measure, responders were those who experienced a 50% or greater reduction in seizure frequency per 28 days from baseline. Due to the sparse PK sampling in this study, the data of this outcome measure were analyzed by pooling the data from other Phase II and III studies of perampanel along with data of this current study, including participants with PGTC seizures. In this outcome measure, responder probability at different concentration values of perampanel when given with or without topiramate (an antiepileptic) has been reported. | Baseline up to 23 weeks |
| Number of Seizure Free Observations During Core Phase of This Study: Assessment Based on Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel | Due to the sparse PK sampling in this study, the data of this outcome measure were analyzed by pooling data from other Phase II and III studies of perampanel along with this current study, including participants with POS or PGTC. Data for this outcome measure have been reported in relationship with different ranges of Cav, ss of Perampanel as "number of observations" those were seizure free for up to 3 visits. The reason for using number of observations for analysis of this outcome measure was because data were available as up to 3 visits per participant and not necessarily that the participant was seizure-free on all three visits. | Baseline up to Week 23 |
| Model Predicted Change From Baseline in Total Aldenkamp-Baker Neuropsychological Assessment Schedule (ABNAS) Score During Core Phase of This Study: Assessment Based on Relationship With Plasma Levels of Perampanel | The ABNAS assessment measured 5 aspects of cognitive function such as fatigue, memory, concentration, motor speed, and reading. The assessment was a measure of participant-perceived cognitive effects of AEDs. This instrument was aimed at assessing participant perceived drug-related cognitive impairment. Total score ranged from 0-72. Higher scores indicate a worsening of these cognitive functions. Analysis for this outcome measure was planned to be performed via Pharmacokinetic/Pharmacodynamic (PK/PD) modelling only if a graphical relationship between perampanel exposure and change from baseline in ABNAS could be discerned. | Baseline up to Week 23 |
| Model Predicted Change From Baseline in Total Child Behavior Check List (CBCL) Score (Participants Aged 4 to 5 Years) During Core Phase of This Study: Assessment Based on Relationship With Plasma Levels of Perampanel | The CBCL for participants with age 4 to 5 years is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: emotionally reactive, anxious/depressed, withdrawn, somatic complaints, internalizing, attention problems, aggressive behavior, externalizing, sleep problems. CBCL total score for participants with age 4 to 5 years ranged from 0 to 200, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in CBCL score (participants aged 4 to 5 years) could be discerned. | Baseline up to Week 23 |
| Model Predicted Change From Baseline in Total Child Behavior Check List (CBCL) Score (Participants Aged Greater Than [>] 5 to <12 Years) During Core Phase of This Study: Assessment Based on Relationship With Plasma Levels of Perampanel | The CBCL for participants with age >5 to <12 years is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: activity, social, school, total competence, anxious/depressed, withdrawn/depressed, somatic complaints, internalizing, rule-breaking behavior, aggressive behavior, externalizing, social problems, thought problems, attention problems. CBCL total score for participants with age >5 to <12 years ranged from 0 to 240, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in CBCL score (participants aged >5 to <12 years) could be discerned. | Baseline up to Week 23 |
| Model Predicted Change From Baseline in Total Time to Complete LGPT Score for Dominant Hand in Core Phase of This Study for All Participants Aged 4 to <12 Years: Assessment Based on Relationship With Plasma Levels of Perampanell | The Lafayette Grooved Pegboard Test (LGPT) measures visuomotor skills. This test is a manipulative dexterity test that consist of a metal matrix of 25 holes with randomly positioned slots. Participants require to insert 10 grooved pegs into the holes. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task is timed and the scores are the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds are recorded for the time. An increase in score (longer time) indicate worsening of visuomotor skills. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in Total Time to Complete LGPT Score for Dominant Hand could be discerned. | Baseline up to Week 23 |
| Model Predicted Change From Baseline in Total Time to Complete LGPT Score for Non-dominant Hand in Core Phase of This Study for All Participants Aged 4 to <12 Years: Assessment Based on Relationship With Plasma Levels of Perampanel | The Lafayette Grooved Pegboard Test (LGPT) measures visuomotor skills. This test is a manipulative dexterity test that consist of a metal matrix of 25 holes with randomly positioned slots. Participants require to insert 10 grooved pegs into the holes. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task is timed and the scores are the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds are recorded for the time. An increase in score (longer time) indicate worsening of visuomotor skills. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in Total Time to Complete LGPT Score for Non-dominant Hand could be discerned. | Baseline up to Week 23 |
| Percentage of Participants With Most Frequent Treatment Emergent Adverse Events (AEs) for Total Group of Participants That Were Considered Related to Perampanel- Core Phase of This Study | Baseline up to 23 weeks |
| Change From Baseline in Aldenkamp-Baker Neuropsychological Assessment Schedule (ABNAS) Score as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | The ABNAS assessment measured 5 aspects of cognitive function such as fatigue, memory, concentration, motor speed, and reading. The assessment was a measure of participant-perceived cognitive effects of AEDs. This instrument was aimed at assessing participant perceived drug-related cognitive impairment. Total score ranged from 0-72. Higher scores indicate a worsening of these cognitive functions. | Baseline, Week 23, Week 52 |
| Change From Baseline in Total Child Behavior Check List (CBCL) Score (Age Group 1.5 to 5 Years) as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | The CBCL for participants (age group 1.5 to 5 years) is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: emotionally reactive, anxious/depressed, withdrawn, somatic complaints, internalizing, attention problems, aggressive behavior, externalizing, sleep problems. CBCL total score for participants (age group 1.5 to 5 years) ranged from 0 to 200, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior. | Baseline, Week 23, Week 52 |
| Change From Baseline in Total Child Behavior Check List (CBCL) Score (Age Group 6 to 18 Years) as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | The CBCL for participants (age group 6 to 18 years) is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: activity, social, school, total competence, anxious/depressed, withdrawn/depressed, somatic complaints, internalizing, rule-breaking behavior, aggressive behavior, externalizing, social problems, thought problems, attention problems. CBCL total score for participants (age group 6 to 18 years) ranged from 0 to 240, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior. | Baseline, Week 23, Week 52 |
| Change From Baseline in Time to Complete Lafayette Grooved Pegboard Test (LGPT) Scores for 8 Years and Under as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | The LGPT test measured visuomotor skills. This test was a manipulative dexterity test that consisted of a metal matrix of 25 holes with randomly positioned slots. The participant was required to insert 10 grooved pegs into the holes. The task was completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task was timed and the scores were the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds were recorded for the time. An increase in score (longer time) indicated worsening of visuomotor skills. The time to complete test is presented as mean seconds plus/minus (+/-) SD. | Baseline, Week 23, Week 52 |
| Change From Baseline in Time to Complete Lafayette Grooved Pegboard Test (LGPT) Scores Over 8 Years as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | The LGPT test measured visuomotor skills. This test was a manipulative dexterity test that consisted of a metal matrix of 25 holes with randomly positioned slots. The participant was required to insert 25 grooved pegs into the holes. The task was completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task was timed and the scores were the time taken for the participant to complete all 25 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds were recorded for the time. An increase in score (longer time) indicated worsening of visuomotor skills. The time to complete test is presented as mean seconds +/- SD. | Baseline, Week 23, Week 52 |
| Change From Baseline in Height (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | Baseline, Week 23, Week 52 |
| Change From Baseline in Weight (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | Baseline, Week 23, Week 52 |
| Change From Baseline in Thyrotropin Value (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | Thyrotropin level was measured in milli-international units per liter (mIU/L). | Baseline, Week 23, Week 52 |
| Change From Baseline in Thyroxine, Free and Triiodothyronine, Free Values (Growth and Development Parameters) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | Baseline, Week 23, Week 52 |
| Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Values (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | Baseline, Week 23, Week 52 |
| Percentage of Participants With Change From Baseline in Markedly Abnormal Encephalogram (EEG) Parameter Values During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study | Baseline up to 52 weeks |
| Number of Encephalogram (EEG) Abnormalities During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study | Baseline up to 52 weeks |
| Percentage of Participants With Any Treatment-emergent Reports of Suicidal Ideation and Behavior Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)- Core Phase and Extension Phase A of This Study | C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and behavior, to assess whether participant experienced any of following: completed suicide, suicide attempt (response of "yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active SI with methods without intent to act or some intent to act, without or with specific plan and intent), any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior").Here, percentage of participants with >=1 positive behavior, participants with >=1 positive ideations; suicidality were reported.An assessment of SI and behavior with C-SSRS performed for participants >=6 years at time of consent. | Up to 52 weeks |
| Percentage of Participants With Shift From Baseline in Suicidal Ideation and Behaviors Assessed Using C-SSRS Scores to Extension Phase A (Week 52) of This Study | The C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and suicidal behavior, to assess whether participant experienced any of the following: completed suicide, suicide attempt (response of "yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active SI with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). "w/" refers to "with", "W" refers to "Week" and "&" refers to "and". | Up to 52 weeks |
| Median Percent Change in Seizure Frequency Per 28 Days During the Treatment Phase Relative to the Pretreatment Phase (Baseline)- Core Phase and Extension Phase A of This Study | Seizure frequency was based on number of seizures per 28 days, calculated as number of seizures over entire time interval divided by number of days in interval and multiplied by 28. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with secondary generalization (SG). Data for this measure has been reported for 13 week time periods as per age groups. | Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 |
| Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study | A 25% responder was a participant who experienced a 25% or greater reduction in seizure frequency per 28 days from baseline. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups. | Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 |
| Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study | A 50% responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days from baseline. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups. | Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 |
| Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study | A 75% responder was a participant who experienced a 75% or greater reduction in seizure frequency per 28 days from baseline. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups. | Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 |
| Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study | Participants were considered seizure free if participants completed a 13-week time period and were seizure-free for that entire time period. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups. | Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 |
| Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study | Assessment of disease severity utilized the CGIC scale at end of treatment to evaluate participant's change in disease status from baseline. The CGIC is a 7-point scale that measures a physician's global impression of a participant's clinical condition. Scale ranged from 1 to 7 with lower score indicated improvement (1=very much improved, 2=much improved, 3=minimally improved), higher score indicated worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicated no change. | Baseline, Week 23, Week 52 |
| Palo Alto |
| California |
| United States |
| Facility #1 | Aurora | Colorado | United States |
| Facility #1 | Gulf Breeze | Florida | United States |
| Facility #1 | Loxahatchee Groves | Florida | United States |
| Facility #1 | Orlando | Florida | United States |
| Facility #1 | Atlanta | Georgia | United States |
| Facility #1 | Savannah | Georgia | United States |
| Facility #1 | Boise | Idaho | United States |
| Facility #1 | Chicago | Illinois | United States |
| Facility #1 | Urbana | Illinois | United States |
| Facility #1 | Ames | Iowa | United States |
| Facility #1 | Wichita | Kansas | United States |
| Facility #1 | Lexington | Kentucky | United States |
| Facility #2 | Lexington | Kentucky | United States |
| Facility #1 | New Orleans | Louisiana | United States |
| Facility #1 | Duluth | Minnesota | United States |
| Facility #1 | Kansas City | Missouri | United States |
| Facility #1 | Henderson | Nevada | United States |
| Facility #1 | Hackensack | New Jersey | United States |
| Facility #1 | Voorhees Township | New Jersey | United States |
| Facility #1 | Brooklyn | New York | United States |
| Facility #1 | Winston-Salem | North Carolina | United States |
| Facility #1 | Cleveland | Ohio | United States |
| Facility #1 | Memphis | Tennessee | United States |
| Facility #1 | Austin | Texas | United States |
| Facility #1 | San Antonio | Texas | United States |
| Facility #1 | Tacoma | Washington | United States |
| Facility #1 | Milwaukee | Wisconsin | United States |
| Facility #1 | Pulderbos | Antwerpen | Belgium |
| Facility #1 | Ottignies | Brabant Wallon | Belgium |
| Facility #1 | Brussels | Brussels Capital | Belgium |
| Facility #1 | La Louvière | Hainaut | Belgium |
| Facility #1 | Brussels | Belgium |
| Facility #1 | Calgary | Alberta | Canada |
| Facility #1 | Montreal | Quebec | Canada |
| Facility #1 | Ostrava | Czechia |
| Facility #1 | Prague | Czechia |
| Facility #1 | Marseille | Bouches-du-Rhone | France |
| Facility #1 | Lille | France |
| Facility #1 | Marseille | France |
| Facility #1 | Paris | France |
| Facility #2 | Paris | France |
| Facility #1 | Strasbourg | France |
| Facility #1 | Toulouse | France |
| Facility #1 | Budapest | Hungary |
| Facility #2 | Budapest | Hungary |
| Facility #1 | Miskolc | Hungary |
| Facility #1 | Pécs | Hungary |
| Facility #1 | Mantua | Lombardy | Italy |
| Facility #1 | Calambrone | Tuscany | Italy |
| Facility #1 | Bologna | Italy |
| Facility #1 | Florence | Italy |
| Facility #1 | Milan | Italy |
| Eisai Trial Site #1 | Sapporo | Hokkaido | Japan |
| Eisai Trial Site #1 | Zentsujichó | Kagawa-ken | Japan |
| Eisai Trial Site #1 | Sendai | Miyagi | Japan |
| Eisai Trial Site #1 | Hamamatsu | Shizuoka | Japan |
| Eisai Trial Site #1 | Fukuoka | Japan |
| Eisai Trial Site #1 | Gifu | Japan |
| Eisai Trial Site #1 | Hakodate-shi | Japan |
| Eisai Trial Site #1 | Hiroshima | Japan |
| Eisai Trial Site #1 | Izumi | Japan |
| Eisai Trial Site #1 | Kobe | Japan |
| Eisai Trial Site #1 | Kumamoto | Japan |
| Eisai Trial Site #1 | Nagoya | Japan |
| Eisai Trial Site #1 | Nara | Japan |
| Eisai Trial Site #1 | Niigata | Japan |
| Eisai Trial Site #1 | Okayama | Japan |
| Eisai Trial Site #1 | Osaka | Japan |
| Eisai Trial Site #1 | Ōmura | Japan |
| Eisai Trial Site #1 | Sagamihara | Japan |
| Eisai Trial Site #1 | Sapporo | Japan |
| Eisai Trial Site #1 | Shizuoka | Japan |
| Eisai Trial Site #1 | Yamagata | Japan |
| Eisai Trial Site #1 | Yokohama | Japan |
| Facility #1 | Riga | Latvia |
| Facility #1 | Poznan | Greater Poland Voivodeship | Poland |
| Facility #1 | Gdansk | Pomeranian Voivodeship | Poland |
| Facility #1 | Kielce | Świętokrzyskie Voivodeship | Poland |
| Facility #1 | Daegu | South Korea |
| Facility #1 | Daejeon | South Korea |
| Facility #1 | Seoul | South Korea |
| Facility #2 | Seoul | South Korea |
| Facility #3 | Seoul | South Korea |
| Facility #1 | Esplugues de Llobregat | Barcelona | Spain |
| Facility #1 | Barcelona | Spain |
| Facility #2 | Barcelona | Spain |
| Facility #1 | Madrid | Spain |
| Facility #1 | Seville | Spain |
| Facility #1 | Valencia | Spain |
| Fogarasi A, Flamini R, Milh M, Phillips S, Yoshitomi S, Patten A, Takase T, Laurenza A, Ngo LY. Open-label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to <12 years) with inadequately controlled focal seizures or generalized tonic-clonic seizures. Epilepsia. 2020 Jan;61(1):125-137. doi: 10.1111/epi.16413. Epub 2020 Jan 7. |
| FG001 | Core Study + Extension Part A: Perampanel 0.5 mg/mL: PGTC Seizures | Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
| FG002 | Extension B: Perampanel 0.5 mg/mL: POS | Participants who completed Core Phase and Extension Phase A and eligible for Extension Phase B entered Extension Phase B, and continued with their optimal perampanel dose from Core Phase until a participant reached 12 years of age, switched to the commercial perampanel product, or discontinued for safety or administrative reasons. |
| FG003 | Extension B: Perampanel 0.5 mg/mL: PGTC Seizures | Participants who completed Core Phase and Extension Phase A and eligible for Extension Phase B entered Extension Phase B, and continued with their optimal perampanel dose from Core Phase until a participant reached 12 years of age, switched to the commercial perampanel product, or discontinued for safety or administrative reasons. |
| COMPLETED |
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| NOT COMPLETED |
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| Extension Phase A (up to 29 Weeks) |
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| Extension Phase B (up to 89 Weeks) |
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Safety Analysis Set (SAS) included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Core Study + Extension Part A: Perampanel 0.5 mg/mL: POS | Core Phase: Participants with partial onset-seizures (POS) received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any EIAED, or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel once daily at optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed Core Phase, entered Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
| BG001 | Core Study + Extension Part A: Perampanel 0.5 mg/mL: PGTC Seizures | Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) for Total Group of Participants - Core Phase and Extension Phase A of This Study | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Posted | Number | percentage of participants | Baseline up to 4 weeks (follow up in Extension Phase A) after last dose of study drug in Extension Phase A at Week 52 (up to 56 weeks) |
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| Primary | Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure and number analyzed 'n' signifies participants who were evaluable for specified categories. | Posted | Number | percentage of participants | Baseline up to 52 weeks |
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| Primary | Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study | Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) of greater than or equal to (>=) 20 or 40 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) >=10 or 20 mmHg; increase or decrease from baseline in pulse rate (number of heart beats per minute [bpm]) of >=15 or 30 bpm. Data for this outcome measure has been assessed and reported till Week 52. | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 52 weeks |
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| Primary | Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 52 weeks |
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| Secondary | Model Predicted Percent Change in Average Seizure Frequency Over 28 Days During Maintenance Period in Core Phase of This Study From Baseline- Assessed as Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel (518 ng/mL) | Seizure frequency derived from information (seizure count and type) recorded in participant diary. Seizure frequency per 28 days was calculated as number of seizures divided by number of days in interval; multiplied by 28. Due to sparse pharmacokinetic (PK) sampling in study, data of endpoint was analyzed by pooling data from other Phase II and III studies of perampanel along with data of this current study, including participants with POS or PGTC. Only data for participants taking perampanel 8 mg/day (corresponding to Cav, ss of 518 ng/mL) were reported. Participants taking perampanel 12 mg/day in studies from which data were pooled, were not included in analysis for this measure. Here, ng/mL= nanogram per milliliter. Data for this measure was calculated through model prediction; reported as "percent change" with measure type as "number" and measure dispersion as "Not applicable, NA". | All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Population for this measure included participants from other studies as well participants from this current study. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Number | percent change | Baseline, Week 23 |
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| Secondary | Overall Responder Probability For Non-Asian Participants With POS During Core Phase of This Study: Assessment Based on Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel | For this outcome measure, responders were those who experienced a 50 percent (%) or greater reduction in seizure frequency per 28 days from baseline. Due to the sparse PK sampling in this study, the data of this outcome measure were pooled with data from other Phase III studies of perampanel conducted in participants with POS. "AEDs not affecting PK" refers to AEDs not affecting PK of perampanel. Data for this outcome measure has been reported for only non-Asian participants with POS per age groups. Responder probability has been reported for Cav,ss of perampanel when given along with different antiepileptic drugs (AEDs). | All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Population for this measure included participants from other studies as well participants from this current study. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Number | Responder probability | Baseline up to 23 weeks |
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| Secondary | Overall Responder Probability For Participants With PGTC Seizures During Core Phase of This Study: Assessment Based on Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel | For this outcome measure, responders were those who experienced a 50% or greater reduction in seizure frequency per 28 days from baseline. Due to the sparse PK sampling in this study, the data of this outcome measure were analyzed by pooling the data from other Phase II and III studies of perampanel along with data of this current study, including participants with PGTC seizures. In this outcome measure, responder probability at different concentration values of perampanel when given with or without topiramate (an antiepileptic) has been reported. | All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Population for this measure included participants from other studies as well participants from this current study. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Number | Responder probability | Baseline up to 23 weeks |
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| Secondary | Number of Seizure Free Observations During Core Phase of This Study: Assessment Based on Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel | Due to the sparse PK sampling in this study, the data of this outcome measure were analyzed by pooling data from other Phase II and III studies of perampanel along with this current study, including participants with POS or PGTC. Data for this outcome measure have been reported in relationship with different ranges of Cav, ss of Perampanel as "number of observations" those were seizure free for up to 3 visits. The reason for using number of observations for analysis of this outcome measure was because data were available as up to 3 visits per participant and not necessarily that the participant was seizure-free on all three visits. | All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Population for this measure included participants from other studies as well participants from this current study. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Count of Units | Seizure free observations | Baseline up to Week 23 | Seizure free observations | Seizure free observations |
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| Secondary | Model Predicted Change From Baseline in Total Aldenkamp-Baker Neuropsychological Assessment Schedule (ABNAS) Score During Core Phase of This Study: Assessment Based on Relationship With Plasma Levels of Perampanel | The ABNAS assessment measured 5 aspects of cognitive function such as fatigue, memory, concentration, motor speed, and reading. The assessment was a measure of participant-perceived cognitive effects of AEDs. This instrument was aimed at assessing participant perceived drug-related cognitive impairment. Total score ranged from 0-72. Higher scores indicate a worsening of these cognitive functions. Analysis for this outcome measure was planned to be performed via Pharmacokinetic/Pharmacodynamic (PK/PD) modelling only if a graphical relationship between perampanel exposure and change from baseline in ABNAS could be discerned. | All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 23 |
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| Secondary | Model Predicted Change From Baseline in Total Child Behavior Check List (CBCL) Score (Participants Aged 4 to 5 Years) During Core Phase of This Study: Assessment Based on Relationship With Plasma Levels of Perampanel | The CBCL for participants with age 4 to 5 years is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: emotionally reactive, anxious/depressed, withdrawn, somatic complaints, internalizing, attention problems, aggressive behavior, externalizing, sleep problems. CBCL total score for participants with age 4 to 5 years ranged from 0 to 200, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in CBCL score (participants aged 4 to 5 years) could be discerned. | All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 23 |
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| Secondary | Model Predicted Change From Baseline in Total Child Behavior Check List (CBCL) Score (Participants Aged Greater Than [>] 5 to <12 Years) During Core Phase of This Study: Assessment Based on Relationship With Plasma Levels of Perampanel | The CBCL for participants with age >5 to <12 years is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: activity, social, school, total competence, anxious/depressed, withdrawn/depressed, somatic complaints, internalizing, rule-breaking behavior, aggressive behavior, externalizing, social problems, thought problems, attention problems. CBCL total score for participants with age >5 to <12 years ranged from 0 to 240, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in CBCL score (participants aged >5 to <12 years) could be discerned. | All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 23 |
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| Secondary | Model Predicted Change From Baseline in Total Time to Complete LGPT Score for Dominant Hand in Core Phase of This Study for All Participants Aged 4 to <12 Years: Assessment Based on Relationship With Plasma Levels of Perampanell | The Lafayette Grooved Pegboard Test (LGPT) measures visuomotor skills. This test is a manipulative dexterity test that consist of a metal matrix of 25 holes with randomly positioned slots. Participants require to insert 10 grooved pegs into the holes. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task is timed and the scores are the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds are recorded for the time. An increase in score (longer time) indicate worsening of visuomotor skills. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in Total Time to Complete LGPT Score for Dominant Hand could be discerned. | All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | seconds | Baseline up to Week 23 |
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| Secondary | Model Predicted Change From Baseline in Total Time to Complete LGPT Score for Non-dominant Hand in Core Phase of This Study for All Participants Aged 4 to <12 Years: Assessment Based on Relationship With Plasma Levels of Perampanel | The Lafayette Grooved Pegboard Test (LGPT) measures visuomotor skills. This test is a manipulative dexterity test that consist of a metal matrix of 25 holes with randomly positioned slots. Participants require to insert 10 grooved pegs into the holes. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task is timed and the scores are the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds are recorded for the time. An increase in score (longer time) indicate worsening of visuomotor skills. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in Total Time to Complete LGPT Score for Non-dominant Hand could be discerned. | All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | seconds | Baseline up to Week 23 |
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| Secondary | Percentage of Participants With Most Frequent Treatment Emergent Adverse Events (AEs) for Total Group of Participants That Were Considered Related to Perampanel- Core Phase of This Study | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Posted | Number | percentage of participants | Baseline up to 23 weeks |
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| Secondary | Change From Baseline in Aldenkamp-Baker Neuropsychological Assessment Schedule (ABNAS) Score as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | The ABNAS assessment measured 5 aspects of cognitive function such as fatigue, memory, concentration, motor speed, and reading. The assessment was a measure of participant-perceived cognitive effects of AEDs. This instrument was aimed at assessing participant perceived drug-related cognitive impairment. Total score ranged from 0-72. Higher scores indicate a worsening of these cognitive functions. | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure and number analyzed 'n' signifies participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 23, Week 52 |
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| Secondary | Change From Baseline in Total Child Behavior Check List (CBCL) Score (Age Group 1.5 to 5 Years) as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | The CBCL for participants (age group 1.5 to 5 years) is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: emotionally reactive, anxious/depressed, withdrawn, somatic complaints, internalizing, attention problems, aggressive behavior, externalizing, sleep problems. CBCL total score for participants (age group 1.5 to 5 years) ranged from 0 to 200, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior. | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure and number analyzed 'n' signifies participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 23, Week 52 |
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| Secondary | Change From Baseline in Total Child Behavior Check List (CBCL) Score (Age Group 6 to 18 Years) as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | The CBCL for participants (age group 6 to 18 years) is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: activity, social, school, total competence, anxious/depressed, withdrawn/depressed, somatic complaints, internalizing, rule-breaking behavior, aggressive behavior, externalizing, social problems, thought problems, attention problems. CBCL total score for participants (age group 6 to 18 years) ranged from 0 to 240, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior. | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure and number analyzed 'n' signifies participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 23, Week 52 |
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| Secondary | Change From Baseline in Time to Complete Lafayette Grooved Pegboard Test (LGPT) Scores for 8 Years and Under as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | The LGPT test measured visuomotor skills. This test was a manipulative dexterity test that consisted of a metal matrix of 25 holes with randomly positioned slots. The participant was required to insert 10 grooved pegs into the holes. The task was completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task was timed and the scores were the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds were recorded for the time. An increase in score (longer time) indicated worsening of visuomotor skills. The time to complete test is presented as mean seconds plus/minus (+/-) SD. | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure and number analyzed 'n' signifies participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | seconds | Baseline, Week 23, Week 52 |
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| Secondary | Change From Baseline in Time to Complete Lafayette Grooved Pegboard Test (LGPT) Scores Over 8 Years as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | The LGPT test measured visuomotor skills. This test was a manipulative dexterity test that consisted of a metal matrix of 25 holes with randomly positioned slots. The participant was required to insert 25 grooved pegs into the holes. The task was completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task was timed and the scores were the time taken for the participant to complete all 25 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds were recorded for the time. An increase in score (longer time) indicated worsening of visuomotor skills. The time to complete test is presented as mean seconds +/- SD. | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure and number analyzed 'n' signifies participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | seconds | Baseline, Week 23, Week 52 |
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| Secondary | Change From Baseline in Height (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure and number analyzed 'n' signifies participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | centimeter (cm) | Baseline, Week 23, Week 52 |
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| Secondary | Change From Baseline in Weight (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here number analyzed 'n' signifies participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline, Week 23, Week 52 |
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| Secondary | Change From Baseline in Thyrotropin Value (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | Thyrotropin level was measured in milli-international units per liter (mIU/L). | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure and number analyzed 'n' signifies participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | mIU/L | Baseline, Week 23, Week 52 |
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| Secondary | Change From Baseline in Thyroxine, Free and Triiodothyronine, Free Values (Growth and Development Parameters) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure and number analyzed 'n' signifies participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | picomoles per liter (pmol/L) | Baseline, Week 23, Week 52 |
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| Secondary | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Values (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure and number analyzed 'n' signifies participants who were evaluable for specified timepoints. | Posted | Mean | Standard Deviation | nanomoles per liter (nmol/L) | Baseline, Week 23, Week 52 |
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| Secondary | Percentage of Participants With Change From Baseline in Markedly Abnormal Encephalogram (EEG) Parameter Values During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Posted | Number | percentage of participants | Baseline up to 52 weeks |
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| Secondary | Number of Encephalogram (EEG) Abnormalities During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Posted | Number | EEG abnormality | Baseline up to 52 weeks |
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| Secondary | Percentage of Participants With Any Treatment-emergent Reports of Suicidal Ideation and Behavior Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)- Core Phase and Extension Phase A of This Study | C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and behavior, to assess whether participant experienced any of following: completed suicide, suicide attempt (response of "yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active SI with methods without intent to act or some intent to act, without or with specific plan and intent), any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior").Here, percentage of participants with >=1 positive behavior, participants with >=1 positive ideations; suicidality were reported.An assessment of SI and behavior with C-SSRS performed for participants >=6 years at time of consent. | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to 52 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Shift From Baseline in Suicidal Ideation and Behaviors Assessed Using C-SSRS Scores to Extension Phase A (Week 52) of This Study | The C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and suicidal behavior, to assess whether participant experienced any of the following: completed suicide, suicide attempt (response of "yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active SI with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). "w/" refers to "with", "W" refers to "Week" and "&" refers to "and". | SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to 52 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Median Percent Change in Seizure Frequency Per 28 Days During the Treatment Phase Relative to the Pretreatment Phase (Baseline)- Core Phase and Extension Phase A of This Study | Seizure frequency was based on number of seizures per 28 days, calculated as number of seizures over entire time interval divided by number of days in interval and multiplied by 28. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with secondary generalization (SG). Data for this measure has been reported for 13 week time periods as per age groups. | Full Analysis Set (FAS) included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here overall number of participants analyzed 'N' signifies participants who were evaluable for this outcome measure and number analyzed 'n' signifies participants who were evaluable for specified timepoints. | Posted | Median | Full Range | percent change | Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 |
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| Secondary | Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study | A 25% responder was a participant who experienced a 25% or greater reduction in seizure frequency per 28 days from baseline. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups. | FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. | Posted | Number | percentage of participants | Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study | A 50% responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days from baseline. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups. | FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. | Posted | Number | percentage of participants | Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study | A 75% responder was a participant who experienced a 75% or greater reduction in seizure frequency per 28 days from baseline. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups. | FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. | Posted | Number | percentage of participants | Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study | Participants were considered seizure free if participants completed a 13-week time period and were seizure-free for that entire time period. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups. | FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. | Posted | Number | percentage of participants | Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study | Assessment of disease severity utilized the CGIC scale at end of treatment to evaluate participant's change in disease status from baseline. The CGIC is a 7-point scale that measures a physician's global impression of a participant's clinical condition. Scale ranged from 1 to 7 with lower score indicated improvement (1=very much improved, 2=much improved, 3=minimally improved), higher score indicated worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicated no change. | FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. | Posted | Number | percentage of participants | Baseline, Week 23, Week 52 |
|
From baseline up to approximately 5 years
SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Core Study + Extension Part A: Perampanel 0.5 mg/mL: POS | Core Phase: Participants with partial onset-seizures (POS) received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any EIAED, or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel once daily at optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed Core Phase, entered Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. | 1 | 149 | 29 | 149 | 135 | 149 |
| EG001 | Core Study + Extension Part A: Perampanel 0.5 mg/mL: PGTC Seizures | Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. | 0 | 31 | 7 | 31 | 25 | 31 |
| EG002 | Extension B: Perampanel 0.5 mg/mL: POS | Participants who completed Core Phase and Extension Phase A and eligible for Extension Phase B entered Extension Phase B, and continued with their optimal perampanel dose from Core Phase until a participant reached 12 years of age, switched to the commercial perampanel product, or discontinued for safety or administrative reasons. | 0 | 41 | 8 | 41 | 34 | 41 |
| EG003 | Extension B: Perampanel 0.5 mg/mL: PGTC Seizures | Participants who completed Core Phase and Extension Phase A and eligible for Extension Phase B entered Extension Phase B, and continued with their optimal perampanel dose from Core Phase until a participant reached 12 years of age, switched to the commercial perampanel product, or discontinued for safety or administrative reasons. | 0 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Viral myocarditis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Epiphysiolysis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Focal dyscognitive seizures | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Petit mal epilepsy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rasmussen encephalitis | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seizure cluster | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Disruptive mood dysregulation disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Benign neoplasm of testis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Cerebral haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 21.0 | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Subgaleal haematoma | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Corneal disorder | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mydriasis | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rubber sensitivity | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Enterocolitis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Eye contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Mallet finger | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Nail avulsion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Scar | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atonic seizures | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Clumsiness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Drooling | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyslexia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysstasia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Focal dyscognitive seizures | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Motor dysfunction | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Persistent postural-perceptual dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Petit mal epilepsy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Postictal state | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Psychomotor skills impaired | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Adjustment disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anger | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bradyphrenia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Defiant behaviour | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysphemia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysphoria | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Enuresis | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Euphoric mood | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypervigilance | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Learning disability | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Middle insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Negativism | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oppositional defiant disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Somnambulism | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tic | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lower respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mechanical urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash morbilliform | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Crying | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Macrocytosis | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Strabismus | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ranula | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Medical device pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Screaming | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Perianal streptococcal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Heat stroke | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Stoma site hypergranulation | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Crystal urine present | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Tri-iodothyronine free increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Periosteal haematoma | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hippocampal sclerosis | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seizure cluster | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Simple partial seizures | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Distractibility | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vesicoureteric reflux | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Precocious puberty | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lagophthalmos | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gingival hypertrophy | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tooth discolouration | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Erythema infectiosum | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Incision site erosion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Ammonia increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blast cell count increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fine motor skill dysfunction | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Subgaleal haematoma | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | +1-888-274-2378 | esi_medinfo@eisai.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 2, 2018 | Feb 5, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C551441 | perampanel |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Inadequate Therapeutic Effect |
|
| Non-specified |
|
| Participant choice |
|
| Other |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Japanese |
|
| Other Asian |
|
| American Indian or Alaska Native |
|
| Other |
|
| Missing |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
| Participants |
|
|
| OG001 | Perampanel: PGTC Seizures | All participants with PGTC seizures who received perampanel 0.5 mg/mL oral suspension (for participants with age <12 years) or tablets (for participants with age >=12 years) titrated to a dose of up to 8 mg/day for up to 23 weeks in studies E2007-G000-232 (NCT01527006) and E2007-G000-332 (NCT01393743) and this current study (E2007-G000-311). |
|
|
All non-Asian participants with POS, received perampanel tablets (participants with age >=12 years) titrated to a dose of up to 8 mg/day or up to 12 mg/day for up to 23 weeks in studies E2007-G000-304 (NCT00699972), E2007-G000-305 (NCT00699582), E2007-G000-306 (NCT00700310), E2007-J000-335 (NCT01618695). |
|
|
| Perampanel: With Topiramate |
All participants with PGTC seizures received perampanel as oral suspension (aged <12 years) or as oral tablets (aged >=12 years) titrated to a dose of up to 8 mg/day or up to 12 mg/day along with topiramate for up to 23 weeks in studies E2007-G000-232 (NCT01527006) and E2007-G000-332 (NCT01393743) and this current study (E2007-G000-311). |
|
|
| OG001 | Perampanel: PGTC Seizures | All participants with PGTC seizures who received perampanel 0.5 mg/mL oral suspension (for participants with age <12 years) or tablets (for participants with age >=12 years) titrated to a dose of up to 8 mg/day for up to 23 weeks in studies E2007-G000-232 (NCT01527006) and E2007-G000-332 (NCT01393743) and this current study (E2007-G000-311). |
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Perampanel 0.5 mg/mL: PGTC Seizures | Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
|
|
| OG001 | Perampanel 0.5 mg/mL: PGTC Seizures | Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
|
|
| OG001 | Perampanel 0.5 mg/mL: PGTC Seizures | Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
|
|
| OG001 | Perampanel 0.5 mg/mL: PGTC Seizures | Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
|
|
| OG001 | Perampanel 0.5 mg/mL: PGTC Seizures | Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
|
|
Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
|
|
Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
|
|
| OG001 | Perampanel 0.5 mg/mL: PGTC Seizures | Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
|
|
| Perampanel 0.5 mg/mL: PGTC Seizures |
Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
|
|
| Perampanel 0.5 mg/mL: PGTC Seizures |
Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
|
|
|
|
|
| OG001 | Perampanel 0.5 mg/mL: PGTC Seizures | Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
|
|
| OG001 | Perampanel 0.5 mg/mL: PGTC Seizures | Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
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| OG001 | Perampanel 0.5 mg/mL: 7 to <12 Years | Core Phase: Participants of age 7 to <12 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
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| OG001 | Perampanel 0.5 mg/mL: 7 to <12 Years | Core Phase: Participants of age 7 to <12 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
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| OG001 | Perampanel 0.5 mg/mL: 7 to <12 Years | Core Phase: Participants of age 7 to <12 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
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| OG001 | Perampanel 0.5 mg/mL: 7 to <12 Years | Core Phase: Participants of age 7 to <12 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
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| OG001 | Perampanel 0.5 mg/mL: 7 to <12 Years | Core Phase: Participants of age 7 to <12 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
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| OG001 | Perampanel 0.5 mg/mL: PGTC Seizures | Core Phase: Participants with primary generalized tonic clonic (PGTC) seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks. |
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