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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002321-35 | EudraCT Number |
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Sponsor's decision
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This study is being conducted to demonstrate that perampanel given as adjunctive anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in participants with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS).
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study of perampanel as adjunctive therapy in participants with inadequately controlled seizures associated with LGS. The study will consist of 3 phases: Prerandomization (4 to 8 weeks), Randomization (18 weeks), and an Extension A (52 weeks). An additional Extension B with open-label treatment will be available for optional participation to participants who reside in Japan and in countries where an expanded access program (EAP) cannot be implemented or has not yet been implemented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perampanel up to 8 mg/day | Experimental | During the Randomization Phase, participants will receive perampanel at a starting dose of 2 milligrams per day (mg/day). Thereafter, the dose will be increased to a maximum target dose of 8 mg/day according to individual tolerability and efficacy for up to 18 weeks. Participants who enter into Extension A will continue to receive perampanel at the dose last received during randomization phase. Participants can be titrated up to 12 mg/day (at 2-week intervals) per the investigator's discretion. Participants who continue in Extension B will continue to receive perampanel at the dose last received at the end of Extension A. |
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| Matching placebo | Placebo Comparator | During the Randomization Phase, participants will receive matching placebo for up to 18 weeks. During the Extension A, participants who received placebo during the Randomization Phase will begin treatment with perampanel in a blinded manner in double-blind Conversion Period, starting at 2 mg/day and then up-titrated to a maximum target dose of 8 mg/day according to individual tolerability and efficacy. After the Conversion Period, participants can be titrated up to 12 mg/day (at 2-week intervals) per the investigator's discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants will receive matching placebo in Randomization phase. |
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| Measure | Description | Time Frame |
|---|---|---|
| Core Study Phase: Median Percent Change in Drop Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Drop seizure was defined as a drop attack or spell involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the participant's position at the time of the attack or spell. Seizure frequency was based on the number of drop seizures per 28 days, calculated as the number of drop seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. | Baseline up to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Core Study Phase: Median Percent Change in Total Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Total seizure was the number of seizures assessed and recorded by the participant's parent/caregiver in the participant seizure diary. Seizure diaries were used to collect seizure counts and types. Seizure frequency was based on the number of drop seizures per 28 days, calculated as the number of drop seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. |
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Inclusion Criteria:
Participants must have a diagnosis of LGS as evidenced by:
Participants must be at least 2 years old at the time of consent/assent
Participants must have been <11 years old at the onset of LGS
Participants must have experienced an average of at least 2 drop seizures per week in the 4-week Baseline Period preceding randomization
Participants must have been receiving 1 to 4 concomitant antiepileptic drugs (AEDs) at a stable dose for at least 30 days before Visit 1 (vagal nerve stimulation (VNS) and ketogenic diet do not count as AEDs). Use of cannabidiol (CBD) products is allowed and is counted as one of the 4 maximum allowed concomitant AEDs. CBD dose and product must have remained stable for at least 30 days before Visit 1 and is to remain the same throughout the course of the Core Study
In the investigator's opinion, parents or caregivers must be able to keep accurate seizure diaries
Body weight at least 8 kilogram (kg)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72202-3500 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33825230 | Derived | Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4. |
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This study included a Core Study Phase and an Extension Phase, which in turn consisted of Extension A and Extension B. Study was terminated early by the sponsor due to recruitment challenges that were further impacted by the COVID-19 pandemic.
Participants took part in the study at 40 investigative sites in Australia, Belgium, the Czech Republic, Japan, India, South Korea, and the United States from 13 December 2016 to 19 July 2021. A total of 101 participants were enrolled (signed informed consent) and 70 participants were randomized to receive study treatment in Core Study Phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Core Study Phase: Placebo | Participants received placebo matched to perampanel oral tablets or placebo matched to perampanel oral suspension, once daily at bedtime during the titration period. During the maintenance period, participants continued to receive the placebo matched to perampanel tablets or placebo matched to perampanel oral suspension at dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in Core Study Phase was 18 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Study (Up to 18 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 | Nov 19, 2018 | Feb 11, 2022 |
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| Perampanel |
| Drug |
Participants will receive perampanel in Randomization phase, open-label Extension A, and open-label Extension B. |
|
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| Baseline up to 18 weeks |
| Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures | Drop seizure was defined as a drop attack or spell involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the participant's position at the time of the attack or spell. A responder was a participant who experienced a 50% or greater reduction in drop seizure frequency per 28 days during Maintenance from prerandomization. | Baseline up to 18 weeks |
| Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Total Seizures | Total seizure was the number of seizures assessed and recorded by the participant's parent/caregiver in the participant seizure diary. Seizure diaries was used to collect seizure counts and types. A responder was a participant who experienced a 50% or greater reduction in drop seizure frequency per 28 days during Maintenance from prerandomization. | Baseline up to 18 weeks |
| Core Study Phase: Median Percent Change in Non-drop Seizure Frequency Per 28 Days During Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) | Non-drop seizures were defined as non-drop attacks or spells. Drop attacks and spells involved the entire body, trunk, or head and lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or could lead to a fall or injury, depending on the participant's position at the time of the attack or spell. Seizure frequency was based on the number of drop seizures per 28 days, calculated as the number of drop seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. | Baseline up to 18 weeks |
| Core Study Phase: Percentage of Participants With 75% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures, Non-drop Seizures and Total Seizures | Drop seizure was defined as a drop attack or spell involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the participant's position at the time of the attack or spell. Non-drop seizures were defined as non-drop attacks or spells. Total seizure was the number of seizures assessed and recorded by the participant's parent/caregiver in the participant seizure diary. Seizure diaries were used to collect seizure counts and types. A responder was a participant who experienced a 75% or greater reduction in drop seizure/non-drop seizure/ frequency per 28 days during Maintenance from prerandomization. | Baseline up to 18 weeks |
| Core Study Phase: Percentage of Participants With 100% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures, Non-drop Seizures and Total Seizures | Drop seizure was defined as a drop attack or spell involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the participant's position at the time of the attack or spell. Non-drop seizures were defined as non-drop attacks or spells. Total seizure was the number of seizures assessed and recorded by the participant's parent/caregiver in the participant seizure diary. Seizure diaries was used to collect seizure counts and types. A responder was a participant who experienced a 100% or greater reduction in drop seizure/non-drop seizure/ frequency per 28 days during Maintenance from prerandomization. | Baseline up to 18 weeks |
| Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Non-drop Seizures | Non-drop seizures were defined as non-drop attacks or spells. Drop attacks and spells involved the entire body, trunk, or head and lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or could lead to a fall or injury, depending on the participant's position at the time of the attack or spell. A responder was a participant who experienced a 50% or greater reduction in non-drop seizure frequency per 28 days during Maintenance from prerandomization. | Baseline up to 18 weeks |
| Core Study Phase: Percentage of Participants With Clinical Global Impression of Change Scores (CGIC) in the Double-blind Treatment Phase | Assessment of disease severity utilized the CGIC scale at end of treatment to evaluate participants change in disease status from baseline. The CGIC is a 7-point likert scale that measures a physician's global impression of a participants 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 up to 18 weeks |
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | A TEAE was defined as an adverse event with an onset date, or a worsening in severity from baseline (pre-treatment), on or after the first dose of study drug up to 28 days following study drug discontinuation. An AE was defined as any untoward medical occurrence in a participant or clinical investigation in a participant administered an investigational product. An AE does not necessarily have a causal relationship with a medicinal product. A serious adverse event (SAE) was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. | From the date of the first administration of the study drug up to 28 days after the last dose of the study drug (up to 192 weeks) |
| Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Values | Treatment-emergent markedly abnormal value for laboratory values was based Common Terminology Criteria for Adverse events (CTCAE) Version 4.0, and determined as if the post baseline CTCAE Version 4.0 grade increases from baseline and the post baseline grade was >=2 (>=3 for phosphate). Laboratory tests included: Hematology count with differential, Chemistry (Electrolytes, Liver function tests, Renal function parameters, Other: albumin, calcium, cholesterol, globulin, glucose, lactate dehydrogenase, phosphorus, total protein, lipid panel, uric acid), Urinalysis, and Viral tests (Hepatitis B surface antigen, Hepatitis C). | From the date of the first administration of the study drug up to 28 days after the last dose of the study drug (up to 192 weeks) |
| Number of Participants With Clinically Significant Vital Signs | Clinically significant means that a value must have met both the criterion value and satisfied the magnitude of change relative to baseline. Vital sign parameters included systolic blood pressure (BP), diastolic BP, pulse rate. | From the date of the first administration of the study drug up to 28 days after the last dose of the study drug (up to 192 weeks) |
| Core Study Phase: Model Predicted Average Perampanel Concentrations at Steady State (Cav,ss) During the Maintenance Period of Core Study Phase | Due to the early termination of the study resulting in reduced sample size and the variability in treatment response, population pharmacokinetic (PK) analysis and population pharmacokinetic/pharmacodynamic (PK/PD) modeling planned for this study were not conducted and hence data was not collected and analyzed for this outcome measure. | Up to Week 18 |
| Palo Alto |
| California |
| 94304 |
| United States |
| Northwest Florida Clinical Research Group, LLC | Gulf Breeze | Florida | 32561 | United States |
| University of Florida Jacksonville | Jacksonville | Florida | 32209 | United States |
| Pediatric Neurologists of Palm Beach | Loxahatchee Groves | Florida | 33470 | United States |
| Axcess Medical Research | Loxahatchee Groves | Florida | United States |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | United States |
| Pediatric Neurology PA | Orlando | Florida | 32819 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30342 | United States |
| Consultants In Epilepsy and Neurology PLLC | Boise | Idaho | 83702 | United States |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Midatlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Mercy Health Saint Mary's Campus | Grand Rapids | Michigan | 49301 | United States |
| Minnesota Epilepsy Group PA | Saint Paul | Minnesota | 55102 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Children's Hospital at Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Cincinnati Children's Hospital Medical Center - PIN | Cincinnati | Ohio | 45229 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| The University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Austin Epilepsy Care Center | Austin | Texas | 78758 | United States |
| Road Runner Research Ltd | San Antonio | Texas | 78249 | United States |
| Baylor Scott and White Research Institute | Temple | Texas | 76508 | United States |
| Clinical Neurosciences Center | Salt Lake City | Utah | 84132 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Columbia Saint Mary's | Milwaukee | Wisconsin | 53211 | United States |
| Medical College of Wisconsin | Wauwatosa | Wisconsin | 53226 | United States |
| Queensland Children's Hospital | South Brisbane | Queensland | 4101 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Royal Brisbane & Women's Hospital | Brisbane | Australia |
| Royal Melbourne Hospital | Melbourne | Australia |
| St Vincent's Hospital Melbourne | Melbourne | Australia |
| The Alfred Hospital | Melbourne | Australia |
| Cliniques Universitaires Saint-Luc | Brussels | Brussels Capital | 1200 | Belgium |
| Hôpital Universitaire des Enfants Reine Fabiola | La Louvière | Hainaut | Belgium |
| Hôpital Erasme | Brussels | Belgium |
| UZ Brussel | Jette | Belgium |
| Centre Neurologique William Lennox | Ottignies-Louvain-la-Neuve | Belgium |
| Fakultni nemocnice Ostrava | Poruba | Czechia |
| Thomayerova nemocnice | Prague | Czechia |
| Synexus Affiliate - Panchshil Hospital | Ahmedabad | Gujarat | India |
| Synexus Affiliate - Nirmal Hospitals Pvt. Ltd | Surat | Gujarat | India |
| Synexus Affiliate - Mallikatta Neuro Center | Mangalore | Karnataka | India |
| Synexus Affiliate - Amrita Institute of Medical Sciences and Research Centre | Kochi | Kerala | India |
| Synexus Affiliate - Jaslok Hospital and Research Centre | Mumbai | Maharashtra | India |
| Synexus Affiliate - Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute | Mumbai | Maharashtra | India |
| Synexus Affiliate - Bharati Hospital | Pune | Maharashtra | India |
| Nizams Institute of Medical Sciences | Hyderabad | 500082 | India |
| Synexus Affiliate - Sir Ganga Ram Hospital | New Delhi | India |
| Eisai Trial Site #1 | Fukuoka | Japan |
| Eisai Trial Site #3 | Fukuoka | Japan |
| Eisai Trial Site #7 | Hakodate | Japan |
| EIsai Trial Site #9 | Kagoshima | Japan |
| Eisai Trial Site #4 | Niigata | Japan |
| EIsai Trial Site #8 | Osaka | 534-0021 | Japan |
| Eisai Trial Site #6 | Sapporo | Japan |
| Eisai Trial Site #2 | Shizuoka | Japan |
| Kyungpook National University Chilgok hospital | Daegu | South Korea |
| Severance Hospital Yonsei University Health System - PPDS | Seoul | 03722 | South Korea |
| Samsung Medical Center - PPDS | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| FG001 | Core Study Phase: Perampanel | Participants received starting dose of perampanel, one 2 milligram (mg) oral tablet or 4 milliliter (mL) oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 milligram per day (mg/day) during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks. |
| FG002 | Extension Phase A: Perampanel | Participants who completed the Core Study Phase and who were eligible entered into Extension Phase A. Participants previously assigned to perampanel arm (Core Study Phase) continued taking study medication at the dose received during the Core maintenance period, and participants previously assigned to a placebo arm (Core Study Phase) started perampanel dose as one 2 mg tablet or 4 mL oral suspension (containing 2 mg perampanel) once daily at bedtime, then up-titrated weekly in 2-mg increments up to a maximum dose of 8 mg/day for 6 weeks conversion period of Extension Phase A. After the conversion period, participants could be titrated up to 12 mg/day in 2-week intervals during the maintenance period (46 weeks) of Extension Phase A as per the investigator's discretion. The total duration of the conversion period and maintenance period in Extension Phase A was 52 weeks. |
| FG003 | Extension Phase B: Perampanel | Participants who completed Extension Phase A and who were eligible entered into Extension Phase B. Participants received perampanel at their optimal perampanel dose (that is, dose maintained at the end of Extension A) until perampanel was available commercially or accessible via extended access program (EAP) (in the country in which a participant resides) or unless study termination by the sponsor (up to 188 weeks). |
| COMPLETED |
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| NOT COMPLETED |
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| Extension Phase A (up to 52 Weeks) |
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| Extension Phase B (up to 188 Weeks) |
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The safety analysis set (SAS) was the group of participants who received at least one dose of study drug and had at least one post-dose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Core Study Phase: Placebo | Participants received placebo matched to perampanel oral tablets or placebo matched to perampanel oral suspension, once daily at bedtime during the titration period. During the maintenance period, participants continued to receive the placebo matched to perampanel tablets or placebo matched to perampanel oral suspension at dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in Core Study Phase was 18 weeks. |
| BG001 | Core Study Phase: Perampanel | Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 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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| Age, Customized | Count of Participants | Participants |
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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 (NIH/OMB) | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Core Study Phase: Median Percent Change in Drop Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Drop seizure was defined as a drop attack or spell involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the participant's position at the time of the attack or spell. Seizure frequency was based on the number of drop seizures per 28 days, calculated as the number of drop seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. | The full analysis set (FAS) was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. | Posted | Median | Full Range | percent change | Baseline up to 18 weeks |
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| Secondary | Core Study Phase: Median Percent Change in Total Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Total seizure was the number of seizures assessed and recorded by the participant's parent/caregiver in the participant seizure diary. Seizure diaries were used to collect seizure counts and types. Seizure frequency was based on the number of drop seizures per 28 days, calculated as the number of drop seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. | Posted | Median | Full Range | percent change | Baseline up to 18 weeks |
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| Secondary | Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures | Drop seizure was defined as a drop attack or spell involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the participant's position at the time of the attack or spell. A responder was a participant who experienced a 50% or greater reduction in drop seizure frequency per 28 days during Maintenance from prerandomization. | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. | Posted | Number | percentage of participants | Baseline up to 18 weeks |
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| Secondary | Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Total Seizures | Total seizure was the number of seizures assessed and recorded by the participant's parent/caregiver in the participant seizure diary. Seizure diaries was used to collect seizure counts and types. A responder was a participant who experienced a 50% or greater reduction in drop seizure frequency per 28 days during Maintenance from prerandomization. | The FAS was the group of randomized participants who received at least one dose of study drug and had at least one post-dose seizure measurement. | Posted | Number | percentage of participants | Baseline up to 18 weeks |
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| Secondary | Core Study Phase: Median Percent Change in Non-drop Seizure Frequency Per 28 Days During Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) | Non-drop seizures were defined as non-drop attacks or spells. Drop attacks and spells involved the entire body, trunk, or head and lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or could lead to a fall or injury, depending on the participant's position at the time of the attack or spell. Seizure frequency was based on the number of drop seizures per 28 days, calculated as the number of drop seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. | The FAS was the group of randomized participants who received at least one dose of study drug and had at least one post-dose seizure measurement. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure. | Posted | Median | Full Range | percent change | Baseline up to 18 weeks |
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| Secondary | Core Study Phase: Percentage of Participants With 75% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures, Non-drop Seizures and Total Seizures | Drop seizure was defined as a drop attack or spell involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the participant's position at the time of the attack or spell. Non-drop seizures were defined as non-drop attacks or spells. Total seizure was the number of seizures assessed and recorded by the participant's parent/caregiver in the participant seizure diary. Seizure diaries were used to collect seizure counts and types. A responder was a participant who experienced a 75% or greater reduction in drop seizure/non-drop seizure/ frequency per 28 days during Maintenance from prerandomization. | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories. | Posted | Number | percentage of participants | Baseline up to 18 weeks |
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| Secondary | Core Study Phase: Percentage of Participants With 100% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures, Non-drop Seizures and Total Seizures | Drop seizure was defined as a drop attack or spell involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the participant's position at the time of the attack or spell. Non-drop seizures were defined as non-drop attacks or spells. Total seizure was the number of seizures assessed and recorded by the participant's parent/caregiver in the participant seizure diary. Seizure diaries was used to collect seizure counts and types. A responder was a participant who experienced a 100% or greater reduction in drop seizure/non-drop seizure/ frequency per 28 days during Maintenance from prerandomization. | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories. | Posted | Number | percentage of participants | Baseline up to 18 weeks |
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| Secondary | Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Non-drop Seizures | Non-drop seizures were defined as non-drop attacks or spells. Drop attacks and spells involved the entire body, trunk, or head and lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or could lead to a fall or injury, depending on the participant's position at the time of the attack or spell. A responder was a participant who experienced a 50% or greater reduction in non-drop seizure frequency per 28 days during Maintenance from prerandomization. | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 18 weeks |
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| Secondary | Core Study Phase: Percentage of Participants With Clinical Global Impression of Change Scores (CGIC) in the Double-blind Treatment Phase | Assessment of disease severity utilized the CGIC scale at end of treatment to evaluate participants change in disease status from baseline. The CGIC is a 7-point likert scale that measures a physician's global impression of a participants 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. | The FAS was the group of randomized participants who received at least one dose of study drug and had at least one post-dose seizure measurement. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 18 weeks |
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| Secondary | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | A TEAE was defined as an adverse event with an onset date, or a worsening in severity from baseline (pre-treatment), on or after the first dose of study drug up to 28 days following study drug discontinuation. An AE was defined as any untoward medical occurrence in a participant or clinical investigation in a participant administered an investigational product. An AE does not necessarily have a causal relationship with a medicinal product. A serious adverse event (SAE) was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. | SAS was group of participants who received at least one dose of study drug and had at least one post-dose safety assessment. As per the planned safety analysis, safety data for Extension A and Extension B was reported together as 'Extension Phase' arm. | Posted | Count of Participants | Participants | From the date of the first administration of the study drug up to 28 days after the last dose of the study drug (up to 192 weeks) |
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| Secondary | Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Values | Treatment-emergent markedly abnormal value for laboratory values was based Common Terminology Criteria for Adverse events (CTCAE) Version 4.0, and determined as if the post baseline CTCAE Version 4.0 grade increases from baseline and the post baseline grade was >=2 (>=3 for phosphate). Laboratory tests included: Hematology count with differential, Chemistry (Electrolytes, Liver function tests, Renal function parameters, Other: albumin, calcium, cholesterol, globulin, glucose, lactate dehydrogenase, phosphorus, total protein, lipid panel, uric acid), Urinalysis, and Viral tests (Hepatitis B surface antigen, Hepatitis C). | SAS was group of participants who received at least one dose of study drug and had at least one post-dose safety assessment. As per the planned safety analysis, safety data for Extension A and Extension B was reported together as 'Extension Phase' arm. | Posted | Count of Participants | Participants | From the date of the first administration of the study drug up to 28 days after the last dose of the study drug (up to 192 weeks) |
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| Secondary | Number of Participants With Clinically Significant Vital Signs | Clinically significant means that a value must have met both the criterion value and satisfied the magnitude of change relative to baseline. Vital sign parameters included systolic blood pressure (BP), diastolic BP, pulse rate. | SAS was group of participants who received at least one dose of the study drug and had at least one post-dose safety assessment. As per the planned safety analysis, safety data for Extension A and Extension B was reported together as 'Extension Phase' arm. | Posted | Count of Participants | Participants | From the date of the first administration of the study drug up to 28 days after the last dose of the study drug (up to 192 weeks) |
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| Secondary | Core Study Phase: Model Predicted Average Perampanel Concentrations at Steady State (Cav,ss) During the Maintenance Period of Core Study Phase | Due to the early termination of the study resulting in reduced sample size and the variability in treatment response, population pharmacokinetic (PK) analysis and population pharmacokinetic/pharmacodynamic (PK/PD) modeling planned for this study were not conducted and hence data was not collected and analyzed for this outcome measure. | The PK analysis set was the group of participants who received perampanel or placebo who had seizure frequency data with documented dosing history. As population PK and PK/PD analysis were not conducted, therefore data was not collected and analyzed. | Posted | Up to Week 18 |
|
From date of first administration of study drug up to 28 days after last dose of study drug (up to 192 weeks)
Participants received varying doses in Extension Phase depending on tolerance. Participants were titrated up to 12 mg/day, hence AEs were summarized as a single arm for Extension Phase. As per the planned safety analysis of Extension Phase, safety data for Extension A and Extension B was reported together in a single arm of Extension Phase.
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 Phase: Placebo | Participants received placebo matched to perampanel oral tablets or placebo matched to perampanel oral suspension, once daily at bedtime during the titration period. During the maintenance period, participants continued to receive the placebo matched to perampanel tablets or placebo matched to perampanel oral suspension at dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in Core Study Phase was 18 weeks. | 0 | 36 | 1 | 36 | 26 | 36 |
| EG001 | Core Study Phase: Perampanel | Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks. | 0 | 34 | 6 | 34 | 29 | 34 |
| EG002 | Extension Phase: Perampanel | Participants who completed Core Study and who were eligible entered Extension A. Participants who received perampanel in Core Study, continued at dose received during Core maintenance period; and participants who received placebo in Core Study started perampanel dose as one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel) once daily at bedtime, then up-titrated weekly in 2-mg increments up to dose of 8 mg/day for 6 weeks conversion period. After conversion period, participants could be titrated up to 12 mg/day in 2-week intervals during maintenance period (46 weeks) as per investigator's discretion. Total duration of conversion and maintenance period in Extension Phase A was 52 weeks. Participants who completed Extension A and who were eligible entered into Extension B in countries where extended access program (EAP) could not be implemented, and received perampanel at optimal dose (dose at end of Extension A) until perampanel was available commercially or unless study termination (up to 188 weeks). | 2 | 58 | 11 | 58 | 50 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cytogenetic abnormality | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sudden unexplained death in epilepsy | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Quadriplegia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Seizure cluster | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Drooling | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
Study was terminated early by sponsor due to recruitment challenge, further impacted by COVID19, resulting in reduced sample size and variability in treatment response. Population PK analysis and PK/PD modeling planned for this study were not conducted and hence data was not collected and analyzed.
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 16, 2021 | Feb 11, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D065768 | Lennox Gastaut Syndrome |
| ID | Term |
|---|---|
| D000073376 | Epileptic Syndromes |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C551441 | perampanel |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Adverse Event |
|
| Study terminated by sponsor |
|
| Other |
|
| Adverse Event |
|
| Study terminated by sponsor |
|
| Other |
|
| Withdrawal by Subject |
|
| Preterm newborn infants (gestational age < 37 wks) |
|
| Newborns (0-27 days) |
|
| Infants and toddlers (28 days-23 months) |
|
| Children (2-11 years) |
|
| Adolescents (12-17 years) |
|
| Adults (18-64 years) |
|
| From 65-84 years |
|
| 85 years and over |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks.
|
|
|
|
| Core Study Phase: Perampanel |
Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks. |
|
|
| OG001 | Core Study Phase: Perampanel | Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks. |
|
|
| OG001 | Core Study Phase: Perampanel | Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks. |
|
|
| Core Study Phase: Perampanel |
Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks. |
|
|
Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks. |
|
|
| OG001 | Core Study Phase: Perampanel | Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks. |
| OG002 | Extension Phase: Perampanel | Participants who completed Core Study and who were eligible entered Extension A. Participants who received perampanel in Core Study, continued at dose received during Core maintenance period, and participants who received placebo in Core Study started perampanel dose as one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel) once daily at bedtime, then up-titrated weekly in 2-mg increments up to dose of 8 mg/day for 6 weeks conversion period. After conversion period, participants could be titrated up to 12 mg/day in 2-week intervals during maintenance period (46 weeks) as per investigator's discretion. Total duration of conversion and maintenance period in Extension Phase A was 52 weeks. Participants who completed Extension A and who were eligible entered into Extension B in countries where extended access program (EAP) could not be implemented, and received perampanel at optimal dose (dose at end of Extension A) until perampanel was available commercially or unless study termination (up to 188 weeks). |
|
|
| OG001 | Core Study Phase: Perampanel | Participants received starting dose of perampanel, one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel), once daily at bedtime then up-titrated weekly in 2 mg increments to a target dose of 8 mg/day during titration period. During the maintenance period, participants continued to receive the perampanel dose level that was administered at the end of the titration period. The total duration of the titration period (6 weeks) and maintenance period (12 weeks) in the Core Study Phase was 18 weeks. |
| OG002 | Extension Phase: Perampanel | Participants who completed Core Study and who were eligible entered Extension A. Participants who received perampanel in Core Study, continued at dose received during Core maintenance period, and participants who received placebo in Core Study started perampanel dose as one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel) once daily at bedtime, then up-titrated weekly in 2-mg increments up to dose of 8 mg/day for 6 weeks conversion period. After conversion period, participants could be titrated up to 12 mg/day in 2-week intervals during maintenance period (46 weeks) as per investigator's discretion. Total duration of conversion and maintenance period in Extension Phase A was 52 weeks. Participants who completed Extension A and who were eligible entered into Extension B in countries where extended access program (EAP) could not be implemented, and received perampanel at optimal dose (dose at end of Extension A) until perampanel was available commercially or unless study termination (up to 188 weeks). |
|
|
| OG002 | Extension Phase: Perampanel | Participants who completed Core Study and who were eligible entered Extension A. Participants who received perampanel in Core Study, continued at dose received during Core maintenance period, and participants who received placebo in Core Study started perampanel dose as one 2 mg oral tablet or 4 mL oral suspension (containing 2 mg perampanel) once daily at bedtime, then up-titrated weekly in 2-mg increments up to dose of 8 mg/day for 6 weeks conversion period. After conversion period, participants could be titrated up to 12 mg/day in 2-week intervals during maintenance period (46 weeks) as per investigator's discretion. Total duration of conversion and maintenance period in Extension Phase A was 52 weeks. Participants who completed Extension A and who were eligible entered into Extension B in countries where extended access program (EAP) could not be implemented, and received perampanel at optimal dose (dose at end of Extension A) until perampanel was available commercially or unless study termination (up to 188 weeks). |
|
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|