Trial Outcomes & Findings for Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures (NCT NCT02849626)

NCT ID: NCT02849626

Last Updated: 2022-10-28

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

180 participants

Primary outcome timeframe

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)

Results posted on

2022-10-28

Participant Flow

Participants took part at 58 investigative sites in the United States, European Union and Asia Pacific from 16 November 2016 to 06 December 2021.

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).

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Core Phase (up to 23 Weeks) STARTED	149	31	0	0
Core Phase (up to 23 Weeks) COMPLETED	122	24	0	0
Core Phase (up to 23 Weeks) NOT COMPLETED	27	7	0	0
Extension Phase A (up to 29 Weeks) STARTED	116	20	0	0
Extension Phase A (up to 29 Weeks) COMPLETED	105	17	0	0
Extension Phase A (up to 29 Weeks) NOT COMPLETED	11	3	0	0
Extension Phase B (up to 89 Weeks) STARTED	0	0	41	1
Extension Phase B (up to 89 Weeks) COMPLETED	0	0	36	1
Extension Phase B (up to 89 Weeks) NOT COMPLETED	0	0	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Core Phase (up to 23 Weeks) Adverse Event	11	3	0
Core Phase (up to 23 Weeks) Withdrawal by Subject	7	2	0
Core Phase (up to 23 Weeks) Inadequate Therapeutic Effect	6	2	0
Core Phase (up to 23 Weeks) Non-specified	3	0	0
Extension Phase A (up to 29 Weeks) Adverse Event	3	2	0
Extension Phase A (up to 29 Weeks) Withdrawal by Subject	4	0	0
Extension Phase A (up to 29 Weeks) Inadequate Therapeutic Effect	3	1	0
Extension Phase A (up to 29 Weeks) Non-specified	1	0	0
Extension Phase B (up to 89 Weeks) Inadequate Therapeutic Effect	0	0	3
Extension Phase B (up to 89 Weeks) Participant choice	0	0	1
Extension Phase B (up to 89 Weeks) Other	0	0	1

Baseline Characteristics

Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Core Study + Extension Part A: Perampanel 0.5 mg/mL: POS n=149 Participants 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.	Core Study + Extension Part A: Perampanel 0.5 mg/mL: PGTC Seizures n=31 Participants 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.	Total n=180 Participants Total of all reporting groups
Age, Continuous	8.1 years STANDARD_DEVIATION 2.10 • n=5 Participants	8.5 years STANDARD_DEVIATION 2.03 • n=7 Participants	8.1 years STANDARD_DEVIATION 2.09 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	11 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	20 Participants n=7 Participants	92 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	141 Participants n=5 Participants	19 Participants n=7 Participants	160 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White	70 Participants n=5 Participants	23 Participants n=7 Participants	93 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	65 Participants n=5 Participants	0 Participants n=7 Participants	65 Participants n=5 Participants
Race/Ethnicity, Customized Other Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Missing	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Population: SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=180 Participants Core Phase: Participants 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 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.	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).
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 Treatment Emergent AEs	90.0 percentage of participants	—
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 Treatment Emergent SAEs	20.0 percentage of participants	—

PRIMARY outcome

Timeframe: Baseline up to 52 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=177 Participants Core Phase: Participants 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 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.	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).
Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Potassium: Markedly Abnormal High	0.6 percentage of participants	—
Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Sodium: Markedly Abnormal Low	1.1 percentage of participants	—
Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Alanine Aminotransferase: Abnormal High	1.1 percentage of participants	—
Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Calcium: Abnormal Low	0.6 percentage of participants	—
Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Gamma Glutamyl Transferase: Abnormal High	2.8 percentage of participants	—
Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Neutrophils: Abnormal Low	9.1 percentage of participants	—
Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Hemoglobin: Abnormal Low	1.7 percentage of participants	—
Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Leukocytes: Abnormal Low	0.6 percentage of participants	—

PRIMARY outcome

Timeframe: Baseline up to 52 weeks

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=179 Participants Core Phase: Participants 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 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.	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).
Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Systolic Blood Pressure: Increment >=20 mmHg	24.6 percentage of participants	—
Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Systolic Blood Pressure: Increment >=40 mmHg	2.2 percentage of participants	—
Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Systolic Blood Pressure: Decrement >=20 mmHg	20.1 percentage of participants	—
Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Systolic Blood Pressure: Decrement >=40 mmHg	0.6 percentage of participants	—
Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Diastolic Blood Pressure: Increment >=10 mmHg	48.0 percentage of participants	—
Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Diastolic Blood Pressure: Increment >=20 mmHg	26.8 percentage of participants	—
Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Diastolic Blood Pressure: Decrement >=10 mmHg	38.0 percentage of participants	—
Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Diastolic Blood Pressure: Decrement >=20 mmHg	16.8 percentage of participants	—
Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Pulse: Increment >=15 bpm	35.8 percentage of participants	—
Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Pulse: Increment >=30 bpm	11.7 percentage of participants	—
Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Pulse: Decrement >=15 bpm	39.7 percentage of participants	—
Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study Pulse: Decrement >=30 bpm	13.4 percentage of participants	—

PRIMARY outcome

Timeframe: Baseline up to 52 weeks

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=174 Participants Core Phase: Participants 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 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.	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).
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study QTc Bazett: Increase of >60 msec	0 percentage of participants	—
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study QTc Bazett: Increase of >30 millisecond (msec)	8.0 percentage of participants	—
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study QTc Bazett: >450 msec	4.0 percentage of participants	—
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study QTc Bazett: >480 msec	0 percentage of participants	—
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study QTc Bazett: >500 msec	0 percentage of participants	—
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study QTc Fridericia: Increase of >30 msec	5.2 percentage of participants	—
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study QTc Fridericia: Increase of >60 msec	0 percentage of participants	—
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study QTc Fridericia: >450 msec	0 percentage of participants	—
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study QTc Fridericia: >480 msec	0 percentage of participants	—
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study QTc Fridericia: >500 msec	0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 23

Population: 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.

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".

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=1371 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=92 Participants 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).
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)	-43.1 percent change	-63.6 percent change

SECONDARY outcome

Timeframe: Baseline up to 23 weeks

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).

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=123 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=1420 Participants 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).
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 8 mg/day+ AEDs not affecting PK:Cav ss 518 ng/mL	0.605 Responder probability	0.466 Responder probability
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 12 mg/day+ AEDs not affecting PK:Cav ss 778 ng/mL	0.669 Responder probability	0.535 Responder probability
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 8 mg/day+ Oxcarbazepine/Phenytoin:Cav ss 258 ng/mL	0.520 Responder probability	0.382 Responder probability
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 12 mg/day+Oxcarbazepine/Phenytoin:Cav ss 387 ng/mL	0.565 Responder probability	0.426 Responder probability
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 8 mg/day+ Carbamazepine:Cav ss 175 ng/mL	0.485 Responder probability	0.350 Responder probability
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 12 mg/day+ Carbamazepine:Cav ss 263 ng/mL	0.522 Responder probability	0.384 Responder probability

SECONDARY outcome

Timeframe: Baseline up to 23 weeks

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=138 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=31 Participants 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).
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 0 ng/mL	0.46 Responder probability	0.26 Responder probability
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 100 ng/mL	0.71 Responder probability	0.50 Responder probability
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 200 ng/mL	0.74 Responder probability	0.54 Responder probability
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 300 ng/mL	0.76 Responder probability	0.57 Responder probability
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 400 ng/mL	0.77 Responder probability	0.58 Responder probability
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 500 ng/mL	0.78 Responder probability	0.59 Responder probability
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 600 ng/mL	0.79 Responder probability	0.60 Responder probability
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 700 ng/mL	0.80 Responder probability	0.61 Responder probability
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 800 ng/mL	0.80 Responder probability	0.62 Responder probability
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 900 ng/mL	0.80 Responder probability	0.63 Responder probability
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 1000 ng/mL	0.81 Responder probability	0.63 Responder probability
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 1200 ng/mL	0.82 Responder probability	0.64 Responder probability
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 1400 ng/mL	0.82 Responder probability	0.65 Responder probability
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 1600 ng/mL	0.82 Responder probability	0.66 Responder probability
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 1800 ng/mL	0.83 Responder probability	0.66 Responder probability
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 2000 ng/mL	0.83 Responder probability	0.67 Responder probability
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 2200 ng/mL	0.84 Responder probability	0.67 Responder probability
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 2400 ng/mL	0.84 Responder probability	0.68 Responder probability

SECONDARY outcome

Timeframe: Baseline up to Week 23

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=3974 Seizure free observations Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=255 Seizure free observations 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).
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 >0 to <500 ng/mL	275 Seizure free observations	57 Seizure free observations
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 500 to <1000 ng/mL	103 Seizure free observations	67 Seizure free observations
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 1000 to <1500 ng/mL	33 Seizure free observations	11 Seizure free observations
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 1500 to 2000 ng/mL	7 Seizure free observations	4 Seizure free observations
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 >2000 ng/mL	0 Seizure free observations	3 Seizure free observations

SECONDARY outcome

Timeframe: Baseline up to Week 23

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=148 Participants Core Phase: Participants 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 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.	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).
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	NA score on a scale Standard Deviation NA No discernible graphical relationship between plasma level of perampanel and change from baseline in ABNAS score was observed to warrant further PK/PD modelling and to summarize the data.	—

SECONDARY outcome

Timeframe: Baseline up to Week 23

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=19 Participants Core Phase: Participants 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 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.	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).
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	NA score on a scale Standard Deviation NA No discernible graphical relationship between plasma level of perampanel and change from baseline in CBCL score (Participants Aged 4 to 5 Years) was observed to warrant further PK/PD modelling and to summarize the data.	—

SECONDARY outcome

Timeframe: Baseline up to Week 23

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=115 Participants Core Phase: Participants 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 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.	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).
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	NA score on a scale Standard Deviation NA No discernible graphical relationship between plasma level of perampanel and change from baseline in CBCL Score (Participants Aged \>5 to \<12 Years) was observed to warrant further PK/PD modelling and to summarize the data.	—

SECONDARY outcome

Timeframe: Baseline up to Week 23

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=117 Participants Core Phase: Participants 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 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.	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).
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	NA seconds Standard Deviation NA No discernible graphical relationship between plasma level of perampanel and change from baseline in LGPT Score for Dominant Hand was observed to warrant further PK/PD modelling and to summarize the data.	—

SECONDARY outcome

Timeframe: Baseline up to Week 23

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=113 Participants Core Phase: Participants 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 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.	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).
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	NA seconds Standard Deviation NA No discernible graphical relationship between plasma level of perampanel and change from baseline in LGPT Score for Non-dominant Hand was observed to warrant further PK/PD modelling and to summarize the data.	—

SECONDARY outcome

Timeframe: Baseline up to 23 weeks

Population: SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=180 Participants Core Phase: Participants 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 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.	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).
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 Irritability/Aggression/Agitation	12.8 percentage of participants	—
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 Nasopharyngitis	14.7 percentage of participants	—
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 Influenza	6.4 percentage of participants	—
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 Pyrexia	9.0 percentage of participants	—
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 Somnolence	13.5 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 23, Week 52

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=140 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=30 Participants 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).
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 Change from Baseline at Week 23	-1.2 score on a scale Standard Deviation 12.77	3.3 score on a scale Standard Deviation 12.42
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 Baseline	17.7 score on a scale Standard Deviation 18.96	28.6 score on a scale Standard Deviation 21.01
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 Change from Baseline at Week 52	-3.9 score on a scale Standard Deviation 16.91	-0.2 score on a scale Standard Deviation 14.67

SECONDARY outcome

Timeframe: Baseline, Week 23, Week 52

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=24 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=2 Participants 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).
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 Baseline	35.0 score on a scale Standard Deviation 28.30	54.0 score on a scale Standard Deviation 21.21
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 Change from Baseline at Week 23	-0.3 score on a scale Standard Deviation 14.71	-13.0 score on a scale Standard Deviation NA Standard deviation could not be calculated because only one participants was available for analysis.
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 Change from Baseline at Week 52	-5.7 score on a scale Standard Deviation 14.36	-11.0 score on a scale Standard Deviation NA Standard deviation could not be calculated because only one participants was available for analysis.

SECONDARY outcome

Timeframe: Baseline, Week 23, Week 52

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=123 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=28 Participants 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).
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 Baseline	33.3 score on a scale Standard Deviation 22.66	44.6 score on a scale Standard Deviation 26.16
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 Change from Baseline at Week 23	-0.6 score on a scale Standard Deviation 12.26	-2.2 score on a scale Standard Deviation 22.84
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 Change from Baseline at Week 52	-1.7 score on a scale Standard Deviation 14.51	-0.7 score on a scale Standard Deviation 16.36

SECONDARY outcome

Timeframe: Baseline, Week 23, Week 52

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=51 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=10 Participants 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).
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 Dominant Hand: Baseline	196.4 seconds Standard Deviation 113.12	155.0 seconds Standard Deviation 108.10
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 Dominant Hand: Change from Baseline at Week 23	12.8 seconds Standard Deviation 49.37	-4.3 seconds Standard Deviation 3.79
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 Dominant Hand: Change from Baseline at Week 52	3.9 seconds Standard Deviation 50.50	13.4 seconds Standard Deviation 33.72
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 Non Dominant Hand: Baseline	224.3 seconds Standard Deviation 108.19	169.6 seconds Standard Deviation 106.49
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 Non Dominant Hand: Change from Baseline at Week 23	3.3 seconds Standard Deviation 39.59	-4.3 seconds Standard Deviation 14.98
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 Non Dominant Hand: Change from Baseline at Week 52	2.6 seconds Standard Deviation 46.88	3.4 seconds Standard Deviation 29.35

SECONDARY outcome

Timeframe: Baseline, Week 23, Week 52

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=63 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=11 Participants 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).
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 Dominant Hand: Baseline	189.8 seconds Standard Deviation 103.58	150.7 seconds Standard Deviation 99.68
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 Dominant Hand: Change from Baseline at Week 23	0.1 seconds Standard Deviation 21.77	-11.8 seconds Standard Deviation 35.05
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 Dominant Hand: Change from Baseline at Week 52	3.0 seconds Standard Deviation 21.24	-15.4 seconds Standard Deviation 30.43
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 Non Dominant Hand: Baseline	197.4 seconds Standard Deviation 100.01	159.9 seconds Standard Deviation 84.66
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 Non Dominant Hand: Change from Baseline at Week 23	7.8 seconds Standard Deviation 36.03	-7.0 seconds Standard Deviation 21.98
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 Non Dominant Hand: Change from Baseline at Week 52	2.7 seconds Standard Deviation 23.75	-28.7 seconds Standard Deviation 36.15

SECONDARY outcome

Timeframe: Baseline, Week 23, Week 52

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=149 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=29 Participants 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).
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	126.65 centimeter (cm) Standard Deviation 14.293	131.08 centimeter (cm) Standard Deviation 13.311
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 Change from Baseline Week 23	2.57 centimeter (cm) Standard Deviation 1.926	1.84 centimeter (cm) Standard Deviation 1.111
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 Change from Baseline Week 52	5.97 centimeter (cm) Standard Deviation 2.580	5.82 centimeter (cm) Standard Deviation 2.544

SECONDARY outcome

Timeframe: Baseline, Week 23, Week 52

Population: 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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=149 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=31 Participants 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).
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	28.09 kilogram (kg) Standard Deviation 10.649	30.43 kilogram (kg) Standard Deviation 11.299
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 Change from Baseline at Week 23	1.86 kilogram (kg) Standard Deviation 2.570	1.70 kilogram (kg) Standard Deviation 3.149
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 Change from Baseline at Week 52	3.75 kilogram (kg) Standard Deviation 4.421	3.74 kilogram (kg) Standard Deviation 4.204

SECONDARY outcome

Timeframe: Baseline, Week 23, Week 52

Thyrotropin level was measured in milli-international units per liter (mIU/L).

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=146 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=30 Participants 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).
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 Baseline	2.682 mIU/L Standard Deviation 1.5897	3.080 mIU/L Standard Deviation 2.2919
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 Change from Baseline at Week 23	0.141 mIU/L Standard Deviation 1.0523	-0.519 mIU/L Standard Deviation 1.4828
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 Change from Baseline at Week 52	0.112 mIU/L Standard Deviation 1.2559	-0.632 mIU/L Standard Deviation 1.5632

SECONDARY outcome

Timeframe: Baseline, Week 23, Week 52

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=146 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=30 Participants 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).
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 Thyroxine, free: Baseline	15.29 picomoles per liter (pmol/L) Standard Deviation 3.993	15.37 picomoles per liter (pmol/L) Standard Deviation 2.160
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 Thyroxine, free: Change at Week 23	-0.07 picomoles per liter (pmol/L) Standard Deviation 4.107	-0.38 picomoles per liter (pmol/L) Standard Deviation 2.088
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 Thyroxine, free: Change at Week 52	0.10 picomoles per liter (pmol/L) Standard Deviation 3.868	0.08 picomoles per liter (pmol/L) Standard Deviation 2.968
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 Triiodothyronine, free: Baseline	5.96 picomoles per liter (pmol/L) Standard Deviation 1.061	6.10 picomoles per liter (pmol/L) Standard Deviation 0.812
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 Triiodothyronine, free: Change at Week 23	0.06 picomoles per liter (pmol/L) Standard Deviation 0.915	-0.16 picomoles per liter (pmol/L) Standard Deviation 0.699
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 Triiodothyronine, free: Change at Week 52	0.04 picomoles per liter (pmol/L) Standard Deviation 0.987	-0.04 picomoles per liter (pmol/L) Standard Deviation 1.107

SECONDARY outcome

Timeframe: Baseline, Week 23, Week 52

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=144 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=31 Participants 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).
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	24.2 nanomoles per liter (nmol/L) Standard Deviation 14.83	25.9 nanomoles per liter (nmol/L) Standard Deviation 13.91
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 Change from Baseline Week 23	1.6 nanomoles per liter (nmol/L) Standard Deviation 8.96	0.6 nanomoles per liter (nmol/L) Standard Deviation 7.25
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 Change from Baseline Week 52	6.5 nanomoles per liter (nmol/L) Standard Deviation 9.01	5.1 nanomoles per liter (nmol/L) Standard Deviation 8.02

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=180 Participants Core Phase: Participants 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 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.	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).
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	0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=180 Participants Core Phase: Participants 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 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.	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).
Number of Encephalogram (EEG) Abnormalities During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study	0 EEG abnormality	—

SECONDARY outcome

Timeframe: Up to 52 weeks

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=122 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=27 Participants 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).
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 Participants with >=1 Positive Behavior	0.8 percentage of participants	0 percentage of participants
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 Participants with >= Positive Ideations	1.6 percentage of participants	7.4 percentage of participants
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 Suicidality	1.6 percentage of participants	7.4 percentage of participants

SECONDARY outcome

Timeframe: Up to 52 weeks

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".

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=122 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=27 Participants 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).
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 No Ideation (Baseline) to No Ideation(Week 52)	96.6 percentage of participants	88.9 percentage of participants
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 Wish to be Dead(Baseline) to No ideation(Week 52)	0.9 percentage of participants	3.7 percentage of participants
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 Active w/ Method(Baseline) to No Ideation(Week 52)	0.9 percentage of participants	0 percentage of participants
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 No Ideation(Baseline)to Active Nonspecific(Week52)	0 percentage of participants	3.7 percentage of participants
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 No Ideation(Baseline) to Active w/ Method(Week 52	0.9 percentage of participants	3.7 percentage of participants
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 No Ideation(Baseline)to Active w/ Intent&Plan(W52)	0.9 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=40 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=108 Participants 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).
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 POS Seizures:Weeks 1-13	-47.99 percent change Interval -100.0 to 79.1	-40.97 percent change Interval -100.0 to 549.0
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 POS Seizures:Weeks 14-26	-38.93 percent change Interval -100.0 to 175.0	-50.77 percent change Interval -100.0 to 360.5
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 POS Seizures:Weeks 27-39	-52.53 percent change Interval -100.0 to 344.2	-67.30 percent change Interval -100.0 to 387.9
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 POS Seizures:Weeks 40-52	-58.92 percent change Interval -100.0 to 482.7	-70.33 percent change Interval -100.0 to 436.3
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 PGTC Seizures:Weeks 1-13	-100.00 percent change Interval -100.0 to 2115.9	-70.33 percent change Interval -100.0 to 6783.5
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 PGTC Seizures:Weeks 14-26	-100.00 percent change Interval -100.0 to -7.7	-70.70 percent change Interval -100.0 to 879.1
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 PGTC Seizures:Weeks 27-39	-80.77 percent change Interval -100.0 to -61.5	-65.43 percent change Interval -100.0 to 315.4
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 PGTC Seizures:Weeks 40-52	-100.00 percent change Interval -100.0 to -100.0	-96.54 percent change Interval -100.0 to 658.4

SECONDARY outcome

Timeframe: Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52

Population: FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=46 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=134 Participants 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).
Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 1-13	67.5 percentage of participants	61.1 percentage of participants
Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 14-26	57.9 percentage of participants	71.4 percentage of participants
Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 27-39	71.9 percentage of participants	78.0 percentage of participants
Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 40-52	71.0 percentage of participants	81.8 percentage of participants
Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 1-13	66.7 percentage of participants	73.7 percentage of participants
Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 14-26	66.7 percentage of participants	73.3 percentage of participants
Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 27-39	100.0 percentage of participants	69.2 percentage of participants
Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 40-52	100.0 percentage of participants	63.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52

Population: FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=46 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=134 Participants 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).
Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 1-13	47.5 percentage of participants	45.4 percentage of participants
Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 14-26	44.7 percentage of participants	50.5 percentage of participants
Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 27-39	53.1 percentage of participants	65.9 percentage of participants
Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 40-52	61.3 percentage of participants	62.3 percentage of participants
Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 1-13	66.7 percentage of participants	57.9 percentage of participants
Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 14-26	66.7 percentage of participants	60.0 percentage of participants
Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 27-39	100.0 percentage of participants	61.5 percentage of participants
Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 40-52	100.0 percentage of participants	54.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52

Population: FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=46 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=134 Participants 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).
Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 1-13	17.5 percentage of participants	25.0 percentage of participants
Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 14-26	18.4 percentage of participants	34.1 percentage of participants
Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 27-39	31.3 percentage of participants	46.3 percentage of participants
Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 40-52	38.7 percentage of participants	41.6 percentage of participants
Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 1-13	66.7 percentage of participants	47.4 percentage of participants
Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 14-26	66.7 percentage of participants	46.7 percentage of participants
Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 27-39	50.0 percentage of participants	46.2 percentage of participants
Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 40-52	100.0 percentage of participants	54.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52

Population: FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=46 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=134 Participants 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).
Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 1-13	7.9 percentage of participants	9.9 percentage of participants
Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 14-26	9.4 percentage of participants	15.9 percentage of participants
Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 27-39	12.9 percentage of participants	24.7 percentage of participants
Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study Total POS Seizures: Weeks 40-52	15.0 percentage of participants	20.8 percentage of participants
Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 1-13	66.7 percentage of participants	40.0 percentage of participants
Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 14-26	50.0 percentage of participants	46.2 percentage of participants
Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 27-39	50.0 percentage of participants	45.5 percentage of participants
Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study PGTC Seizures: Weeks 40-52	100.0 percentage of participants	57.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 23, Week 52

Population: FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.

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.

Outcome measures

Outcome measures
Measure	Perampanel 0.5 mg/mL: All Participants n=149 Participants Core Phase: Participants 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 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.	Perampanel: PGTC Seizures n=31 Participants 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).
Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study Week 23: Very much improved	11.5 percentage of participants	8.7 percentage of participants
Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study Week 23: Much improved	31.1 percentage of participants	26.1 percentage of participants
Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study Week 23: Minimally improved	38.5 percentage of participants	26.1 percentage of participants
Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study Week 23: No change	14.8 percentage of participants	26.1 percentage of participants
Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study Week 23: Minimally worse	3.3 percentage of participants	13.0 percentage of participants
Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study Week 23: Much worse	0.8 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study Week 52: Very much improved	14.4 percentage of participants	5.9 percentage of participants
Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study Week 52: Much improved	39.4 percentage of participants	41.2 percentage of participants
Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study Week 52: Minimally improved	35.6 percentage of participants	29.4 percentage of participants
Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study Week 52: No change	7.7 percentage of participants	17.6 percentage of participants
Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study Week 52: Minimally worse	1.9 percentage of participants	5.9 percentage of participants
Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study Week 52: Much worse	1.0 percentage of participants	0 percentage of participants

Adverse Events

Core Study + Extension Part A: Perampanel 0.5 mg/mL: POS

Serious events: 29 serious events

Other events: 135 other events

Deaths: 1 deaths

Core Study + Extension Part A: Perampanel 0.5 mg/mL: PGTC Seizures

Serious events: 7 serious events

Other events: 25 other events

Deaths: 0 deaths

Extension B: Perampanel 0.5 mg/mL: POS

Serious events: 8 serious events

Other events: 34 other events

Deaths: 0 deaths

Extension B: Perampanel 0.5 mg/mL: PGTC Seizures

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Eisai Medical Information

Eisai Inc.

Phone: +1-888-274-2378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place