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

• Sponsor: Eisai Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02849626
• Collaborator: (none)
• Enrollment: 208
• Locations: 92
• Arm: 1
• Actual Duration (Months): 60.6
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than [<] 12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic (PGTC) seizures.

Condition or Disease	Intervention/Treatment	Phase
Partial-Onset or Primary Generalized Tonic-Clonic Seizures	Drug: Perampanel	Phase 3

Detailed Description

This is a multicenter, open-label, single-arm study in children (age 4 to <12 years) with inadequately controlled POS or PGTC seizures. The study will consist of a Core Phase and two Extension Phases (Extension Phase A [for all countries in the study], and Extension Phase B [available for participants enrolled in Japan and in countries where an extended access program cannot be implemented, after completion of Extension Phase A]). The Core Phase will consist of the following 2 phases: Pretreatment and Treatment Phase. The Pretreatment Phase, during which participants will be assessed for eligibility, will consist of up to a 4-weeks +/- 3 days Screening/Baseline Period. The Treatment Phase will consist of 3 periods: Titration Period (up to an 11-weeks: dose titration on the basis of individual clinical response and tolerability), Maintenance Period (up to a 12-weeks: continuation of perampanel oral suspension once daily at the dose level achieved at the end of the Titration Period), and Follow-up Period (up to 4-weeks +/- 7 days: only for those participants not entering into Extension Phase A or those who prematurely discontinue from the study). Extension Phase A will consist of up to 29-weeks Maintenance Period and up to 4-weeks +/- 7 days Follow-up Period after the last dose of perampanel only for participants who did not enter into Extension Phase B. All participants who complete all scheduled visits up to and including Visit 9 in the Treatment Phase will be eligible to participate in Extension Phase A of the study. During the Maintenance Period of Extension Phase A, all participants will continue with their optimal perampanel dose (that is, dose level that they complete on during the Core Phase). After completing Extension Phase A, participants in Japan and in countries where EAP cannot be implemented, participants will be eligible to participate in Extension Phase B. In Japan, treatment will continue as long as clinically appropriate according to the judgment of the investigator. However, treatment of participants in Extension B will be completed when the participant reaches 12 years of age or when perampanel is commercially available in Japan for treatment of POS in pediatric participants (4 to less than 12 years of age). In countries where an EAP cannot be implemented, participation in Extension B will continue as long as clinically appropriate according to the judgment of the investigator, until the participants reaches 12 years of age or perampanel oral suspension is commercially available.

Study Design

• Study Type: Interventional
• Actual Enrollment: 208 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Multicenter Study With an Extension Phase to Evaluate the Safety, Tolerability, and Exposure-Efficacy Relationship of Perampanel Oral Suspension When Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to Less Than 12 Years) With Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic Clonic Seizures
• Actual Study Start Date: Nov 16, 2016
• Actual Primary Completion Date: Feb 5, 2019
• Actual Study Completion Date: Dec 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Perampanel Perampanel 0.5 milligrams per milliliter (mg/mL) oral suspension	Drug: Perampanel; E2007

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) for Total Group of Participants- Core Phase and Extension Phase A of This Study [Baseline up to 4 weeks (follow up in Extension Phase A) after last dose of study drug in Extension Phase A at Week 52 (up to 56 weeks)]

2. Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study [Baseline up to 52 weeks]

3. Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study [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.

4. Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study [Baseline up to 52 weeks]

Secondary Outcome Measures

1. 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) [Baseline, Week 23]

   Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. Due to the sparse pharmacokinetic (PK) sampling in this study, the data of this outcome measure was analyzed by pooling the data from other Phase II and III studies of perampanel along with the 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 the studies from which data were pooled, were not included in analysis for this measure. Here, ng/mL refers to nanogram per milliliter. Data for this measure was calculated through model prediction and reported as "percent change" with measure type as "number" and measure dispersion as "Not applicable, NA".

2. 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 [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).

3. 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 [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.

4. 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 [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.

5. 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 [Baseline up to Week 23]

   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.

6. 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 [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.

7. 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 [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.

8. 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 Perampanel [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.

9. 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 [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 Non-dominant Hand could be discerned.

10. Percentage of Participants With Most Frequent Treatment Emergent Adverse Events (AEs) for Total Group of Participants That Were Considered Related to Perampanel- Core Phase of This Study [Baseline up to 23 weeks]

11. 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, Week 23, Week 52]

    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.

12. 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, 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.

13. 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, 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.

14. 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 [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.

15. 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 [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.

16. Change From Baseline in Height (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [Baseline, Week 23, Week 52]

17. Change From Baseline in Weight (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [Baseline, Week 23, Week 52]

18. 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, Week 23, Week 52]

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

19. Change From Baseline in Thyroxine, Free and Triiodothyronine, Free Values (Growth and Development Parameters) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [Baseline, Week 23, Week 52]

20. Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Values (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [Baseline, Week 23, Week 52]

21. Percentage of Participants With Change From Baseline in Markedly Abnormal Encephalogram (EEG) Parameter Values During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study [Baseline up to 52 weeks]

22. Number of Encephalogram (EEG) Abnormalities During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study [Baseline up to 52 weeks]

23. 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 [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"). Here, percentage of participants with >=1 positive behavior, participants with >=1 positive ideations, and suicidality were reported. An assessment of SI and behavior using the C-SSRS was performed for participants >=6 years at the time of consent.

24. 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 [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"

25. 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 [Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52]

    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.

26. Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study [Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52]

    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.

27. Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study [Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52]

    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.

28. Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study [Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52]

    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.

29. Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study [Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52]

    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.

30. Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study [Baseline, Week 23, Week 52]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have a diagnosis of epilepsy with POS with or without secondarily generalized (SG) seizures or PGTC seizures according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures (1981). A diagnosis should have been established at least 6 months prior to Visit 1 by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (that is, clinical history)

• Male or female participant, from age 4 to <12 years at the time of informed consent/assent

• Have a minimum weight of 16 kilograms (kg) (35 pounds [lb])

• Have had a brain imaging (example, magnetic resonance imaging [MRI] scan or computed tomography [CT] before Visit 1 that ruled out a progressive cause of epilepsy)

• During the 12 weeks +/- 3 days (4 weeks +/- 3 days in Japan only) prior to Visit 2, participants must have equal or greater than (=>) one POS or one PGTC seizure. Only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS

• Are currently being treated with stable doses of 1 to a maximum of 3 approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before to Visit 1; in the case where a new AED regimen has been initiated for a participant, the dose must be stable for at least 8 weeks prior to Visit 1. Only one EIAED (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of three AEDs is allowed (A vagal nerve stimulator [VNS] will be counted as one of the 3 allowed AEDs)

Exclusion Criteria:

• Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 International Units per liter [IU/L] or equivalent units of β-hCG or hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug

• Females of childbearing potential who:

• Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (example, total abstinence, an intrauterine device, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation. If a highly effective method is not appropriate or acceptable for the participant, then the participant may use a medically effective method (example, a double barrier method such as condom plus diaphragm with spermicide)

• Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from being sexually active during the study period or for 28 days after study drug discontinuation

• Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation

• Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before Visit 1

• Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1

• Have an unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified tests (example, significant suicide risk, including suicidal behavior and ideation within 6 months before Visit 1, current psychotic disorder, acute mania)

• Any suicidal ideation with intent with or without a plan within 6 months before Visit 2 (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale [C-SSRS]) in participants aged 6 and above

• Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however, those who have previously documented "failed" epilepsy surgery will be allowed

• Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments

• Evidence of moderate or severe renal insufficiency as defined by estimated glomerular filtration rates (eGFRs) of 31 to <60 milliliters per minute (mL/min) and <30 mL/min, respectively

• Evidence of significant active hepatic disease. Stable elevation of liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) due to concomitant medication(s), will be allowed if they are less than 3 times the upper limit of normal (ULN)

• Evidence of significant active hematological disease; white blood cell (WBC) count equal or less than (=<) 2500 per (/) microliter (µL) (2.50 1 constant [E]+09/liter [L]) or an absolute neutrophil count =<1000/µL (1.00 1E+09/L)

• Clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as greater than (>) 450 milliseconds (msec)

• Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors

• Multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (example, Stevens Johnson syndrome), hematological, or organ toxicity reactions.

• Concomitant use of felbamate as an AED for <2 years or where the dose has not been stable for at least 8 weeks before Visit 1. Participants must not have a history of WBC count =<2500/µL, platelets below 100,000, liver function tests (LFTs) above 3 times the ULN, or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If participants received felbamate in the past, it must have been discontinued 8 weeks before Visit 1 to be eligible for study participation

• Concomitant use of vigabatrin: participants who took vigabatrin in the past must be off vigabatrin for at least 5 months before Visit 1 and with documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in a visual perimetry test

• Concomitant use of cannabinoids

• Used benzodiazepines for epilepsy during which the dose has not been stable for >4 weeks prior to Visit 1. Benzodiazepines use as rescue medication for seizure control is allowed; however, intermittent use of benzodiazepines for any other indication (example, anxiety/sleep disorders) is prohibited

• A VNS implanted <5 months before Visit 1 or changes in parameter <4 weeks before Visit 1 (or thereafter during the study)

• On a ketogenic diet for which the diet is not a stable regimen for at least 4 weeks before Visit 1

• History of or a concomitant medical condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study or compromise the participant's ability to safely complete the study

• Have previously been exposed to perampanel in a clinical trial or by prescription for more than 2 months or discontinued for Adverse Events (AEs)

• Have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer

• Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Facility #1	Little Rock	Arkansas	United States
2	Facility #1	Palo Alto	California	United States
3	Facility #1	Aurora	Colorado	United States
4	Facility #1	Gulf Breeze	Florida	United States
5	Facility #1	Loxahatchee Groves	Florida	United States
6	Facility #1	Orlando	Florida	United States
7	Facility #1	Atlanta	Georgia	United States
8	Facility #1	Savannah	Georgia	United States
9	Facility #1	Boise	Idaho	United States
10	Facility #1	Chicago	Illinois	United States
11	Facility #1	Urbana	Illinois	United States
12	Facility #1	Ames	Iowa	United States
13	Facility #1	Wichita	Kansas	United States
14	Facility #1	Lexington	Kentucky	United States
15	Facility #2	Lexington	Kentucky	United States
16	Facility #1	New Orleans	Louisiana	United States
17	Facility #1	Duluth	Minnesota	United States
18	Facility #1	Kansas City	Missouri	United States
19	Facility #1	Henderson	Nevada	United States
20	Facility #1	Hackensack	New Jersey	United States
21	Facility #1	Voorhees	New Jersey	United States
22	Facility #1	Brooklyn	New York	United States
23	Facility #1	Winston-Salem	North Carolina	United States
24	Facility #1	Cleveland	Ohio	United States
25	Facility #1	Memphis	Tennessee	United States
26	Facility #1	Austin	Texas	United States
27	Facility #1	San Antonio	Texas	United States
28	Facility #1	Tacoma	Washington	United States
29	Facility #1	Milwaukee	Wisconsin	United States
30	Facility #1	Pulderbos	Antwerpen	Belgium
31	Facility #1	Ottignies	Brabant Wallon	Belgium
32	Facility #1	Bruxelles	Brussels	Belgium
33	Facility #1	La Louviere	Hainaut	Belgium
34	Facility #1	Brussels		Belgium
35	Facility #1	Calgary	Alberta	Canada
36	Facility #1	Montreal	Quebec	Canada
37	Facility #1	Ostrava		Czechia
38	Facility #1	Praha 4		Czechia
39	Facility #1	Marseille	Bouches-du-Rhone	France
40	Facility #1	Lille Cedex		France
41	Facility #1	Marseille		France
42	Facility #1	Paris		France
43	Facility #2	Paris		France
44	Facility #1	Strasbourg		France
45	Facility #1	Toulouse Cedex 9		France
46	Facility #1	Budapest		Hungary
47	Facility #2	Budapest		Hungary
48	Facility #1	Miskolc		Hungary
49	Facility #1	Pecs		Hungary
50	Facility #1	Mantova	Lombardia	Italy
51	Facility #1	Calambrone	Toscana	Italy
52	Facility #1	Bologna		Italy
53	Facility #1	Firenze		Italy
54	Facility #1	Milano		Italy
55	Eisai Trial Site #1	Sapporo	Hokkaido	Japan
56	Eisai Trial Site #1	Zentsuji	Kagawa	Japan
57	Eisai Trial Site #1	Sendai-shi	Miyagi	Japan
58	Eisai Trial Site #1	Hamamatsu	Sizuoka	Japan
59	Eisai Trial Site #1	Fukuoka-shi		Japan
60	Eisai Trial Site #1	Fukuoka		Japan
61	Eisai Trial Site #1	Gifu		Japan
62	Eisai Trial Site #1	Hakodate-shi		Japan
63	Eisai Trial Site #1	Hiroshima		Japan
64	Eisai Trial Site #1	Izumi		Japan
65	Eisai Trial Site #1	Kobe		Japan
66	Eisai Trial Site #1	Kumamoto		Japan
67	Eisai Trial Site #1	Nagoya		Japan
68	Eisai Trial Site #1	Nara		Japan
69	Eisai Trial Site #1	Niigata		Japan
70	Eisai Trial Site #1	Okayama		Japan
71	Eisai Trial Site #1	Omura		Japan
72	Eisai Trial Site #1	Osaka		Japan
73	Eisai Trial Site #1	Sagamihara		Japan
74	Eisai Trial Site #1	Sapporo		Japan
75	Eisai Trial Site #1	Shizuoka		Japan
76	Eisai Trial Site #1	Yamagata		Japan
77	Eisai Trial Site #1	Yokohama-shi		Japan
78	Facility #1	Daegu		Korea, Republic of
79	Facility #1	Daejeon		Korea, Republic of
80	Facility #1	Seoul		Korea, Republic of
81	Facility #2	Seoul		Korea, Republic of
82	Facility #3	Seoul		Korea, Republic of
83	Facility #1	Riga		Latvia
84	Facility #1	Gdansk	Pomorskie	Poland
85	Facility #1	Kielce	Swietokrzyskie	Poland
86	Facility #1	Poznan	Wielkopolskie	Poland
87	Facility #1	Esplugues de Llobregat	Barcelona	Spain
88	Facility #1	Barcelona		Spain
89	Facility #2	Barcelona		Spain
90	Facility #1	Madrid		Spain
91	Facility #1	Sevilla		Spain
92	Facility #1	Valencia		Spain

Sponsors and Collaborators

• Eisai Inc.

Investigators

• : Eisai Medical Information, Eisai Inc.

Study Documents (Full-Text)

• Study Protocol - Jul 13, 2018
• Statistical Analysis Plan - Aug 2, 2018

More Information

Publications

None provided.

• Responsible Party: Eisai Inc.
• ClinicalTrials.gov Identifier: NCT02849626
• Other Study ID Numbers: E2007-G000-311; 2014-002167-16
• First Posted: Jul 29, 2016
• Last Update Posted: Jan 20, 2022
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eisai Inc.: Partial-Onset Seizures; Primary Generalized Tonic-Clonic Seizures; Adjunctive Therapy; Epilepsy
• Additional relevant MeSH terms: Seizures

Study Results

Participant Flow

Recruitment Details	Participants took part at 58 investigative sites in the United States, European Union and Asia Pacific. A total of 208 participants were screened and enrolled, of which 28 were screen failures and 180 received study treatment in Core Phase. Of 146 participants who completed the Core Phase, 136 entered Extension Phase A and received study treatment.
Pre-assignment Detail	This study included a Core Phase and two Extension Phases (Extension Phase A and Extension Phase B). This result summary includes data only for the Core Phase and Extension Phase A of the study at the primary completion date (05 February 2019). Extension Phase B results will be provided at the time of study completion date.

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	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 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.
Period Title: Core Phase (up to 23 Weeks)
STARTED	149	31
COMPLETED	122	24
NOT COMPLETED	27	7
Period Title: Core Phase (up to 23 Weeks)
STARTED	116	20
COMPLETED	105	17
NOT COMPLETED	11	3

Baseline Characteristics

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures	Total
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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 of all reporting groups
Overall Participants	149	31	180
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.1 (2.10)	8.5 (2.03)	8.1 (2.09)
Sex: Female, Male (Count of Participants)
Female	77 51.7%	11 35.5%	88 48.9%
Male	72 48.3%	20 64.5%	92 51.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 2%	7 22.6%	10 5.6%
Not Hispanic or Latino	141 94.6%	19 61.3%	160 88.9%
Unknown or Not Reported	5 3.4%	5 16.1%	10 5.6%
Race/Ethnicity, Customized (Count of Participants)
White	70 47%	23 74.2%	93 51.7%
Black or African American	2 1.3%	1 3.2%	3 1.7%
Japanese	65 43.6%	0 0%	65 36.1%
Other Asian	5 3.4%	1 3.2%	6 3.3%
American Indian or Alaska Native	1 0.7%	0 0%	1 0.6%
Other	2 1.3%	1 3.2%	3 1.7%
Missing	4 2.7%	5 16.1%	9 5%

Outcome Measures

1. Primary Outcome

Title	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
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: All Participants
Arm/Group Description	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.
Measure Participants	180
Treatment Emergent AEs	90.0 60.4%
Treatment Emergent SAEs	20.0 13.4%

2. Primary Outcome

Title	Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study
Time Frame	Baseline up to 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: All Participants
Arm/Group Description	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.
Measure Participants	180
Potassium: Markedly Abnormal High	0.6 0.4%
Sodium: Markedly Abnormal Low	1.1 0.7%
Alanine Aminotransferase: Markedly Abnormal High	1.1 0.7%
Calcium: Markedly Abnormal Low	0.6 0.4%
Gamma Glutamyl Transferase: Markedly Abnormal High	2.8 1.9%
Neutrophils: Markedly Abnormal Low	9.1 6.1%
Hemoglobin: Markedly Abnormal Low	1.7 1.1%
Leukocytes: Markedly Abnormal Low	0.6 0.4%

3. Primary Outcome

Title	Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study
Description	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.
Time Frame	Baseline up to 52 weeks

Outcome Measure Data

Analysis Population Description

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" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 0.5 mg/mL: All Participants
Arm/Group Description	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.
Measure Participants	179
Systolic Blood Pressure: Increment >=20 mmHg	24.6 16.5%
Systolic Blood Pressure: Increment >=40 mmHg	2.2 1.5%
Systolic Blood Pressure: Decrement >=20 mmHg	20.1 13.5%
Systolic Blood Pressure: Decrement >=40 mmHg	0.6 0.4%
Diastolic Blood Pressure: Increment >=10 mmHg	48.0 32.2%
Diastolic Blood Pressure: Increment >=20 mmHg	26.8 18%
Diastolic Blood Pressure: Decrement >=10 mmHg	38.0 25.5%
Diastolic Blood Pressure: Decrement >=20 mmHg	16.8 11.3%
Pulse: Increment >=15 bpm	35.8 24%
Pulse: Increment >=30 bpm	11.7 7.9%
Pulse: Decrement >=15 bpm	39.7 26.6%
Pulse: Decrement >=30 bpm	13.4 9%

4. Primary Outcome

Title	Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study
Time Frame	Baseline up to 52 weeks

Outcome Measure Data

Analysis Population Description

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" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 0.5 mg/mL: All Participants
Arm/Group Description	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.
Measure Participants	174
QTc Bazett: Increase of >30 millisecond (msec)	8.0 5.4%
QTc Bazett: Increase of >60 msec	0 0%
QTc Bazett: >450 msec	4.0 2.7%
QTc Bazett: >480 msec	0 0%
QTc Bazett: >500 msec	0 0%
QTc Fridericia: Increase of >30 msec	5.2 3.5%
QTc Fridericia: Increase of >60 msec	0 0%
QTc Fridericia: >450 msec	0 0%
QTc Fridericia: >480 msec	0 0%
QTc Fridericia: >500 msec	0 0%

5. Secondary Outcome

Title	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)
Description	Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. Due to the sparse pharmacokinetic (PK) sampling in this study, the data of this outcome measure was analyzed by pooling the data from other Phase II and III studies of perampanel along with the 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 the studies from which data were pooled, were not included in analysis for this measure. Here, ng/mL refers to nanogram per milliliter. Data for this measure was calculated through model prediction and reported as "percent change" with measure type as "number" and measure dispersion as "Not applicable, NA".
Time Frame	Baseline, Week 23

Outcome Measure Data

Analysis Population Description

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" signifies participants who were evaluable for this measure.

Arm/Group Title	Perampanel: POS	Perampanel: PGTC Seizures
Arm/Group Description	All participants with POS who received perampanel 0.5 mg/mL oral suspension (for participants with age less than [<] 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-G000-304 (NCT00699972), E2007-G000-305 (NCT00699582), E2007-G000-306 (NCT00700310), E2007-J000-335 (NCT01618695) and this current study (E2007-G000-311).	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).
Measure Participants	1371	92
Number [percent change]	-43.1	-63.6

6. Secondary Outcome

Title	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
Description	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).
Time Frame	Baseline up to 23 weeks

Outcome Measure Data

Analysis Population Description

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" signifies participants who were evaluable for this measure.

Arm/Group Title	Perampanel: Participants Aged (<12 Years)	Perampanel: Participants Aged (>=12 Years)
Arm/Group Description	All non-Asian participants with POS, received perampanel oral suspension (participants with age <12 years) titrated to a dose of up to 8 mg/day or up to 12 mg/day for up to 23 weeks in this current study E2007-G000-311.	All non-Asian participants with POS, received perampanel tablets (participants with age >=12 years) titrated to a dose of up to 8 mg/day or up to 12 mg/day for up to 23 weeks in studies E2007-G000-304 (NCT00699972), E2007-G000-305 (NCT00699582), E2007-G000-306 (NCT00700310), E2007-J000-335 (NCT01618695).
Measure Participants	123	1420
8 mg/day+ AEDs not affecting PK:Cav ss 518 ng/mL	0.605	0.466
12 mg/day+ AEDs not affecting PK:Cav ss 778 ng/mL	0.669	0.535
8 mg/day+ Oxcarbazepine/Phenytoin:Cav ss 258 ng/mL	0.520	0.382
12 mg/day+Oxcarbazepine/Phenytoin:Cav ss 387 ng/mL	0.565	0.426
8 mg/day+ Carbamazepine:Cav ss 175 ng/mL	0.485	0.350
12 mg/day+ Carbamazepine:Cav ss 263 ng/mL	0.522	0.384

7. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline up to 23 weeks

Outcome Measure Data

Analysis Population Description

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" signifies participants who were evaluable for this measure.

Arm/Group Title	Perampanel: Without Topiramate	Perampanel: With Topiramate
Arm/Group Description	All participants with PGTC seizures received perampanel as oral suspension (aged <12 years) or as oral tablets (aged >=12 years) titrated to a dose of up to 8 mg/day or up to 12 mg/day without topiramate for up to 23 weeks in studies E2007-G000-232 (NCT01527006) and E2007-G000-332 (NCT01393743) and this current study (E2007-G000-311).	All participants with PGTC seizures received perampanel as oral suspension (aged <12 years) or as oral tablets (aged >=12 years) titrated to a dose of up to 8 mg/day or up to 12 mg/day along with topiramate for up to 23 weeks in studies E2007-G000-232 (NCT01527006) and E2007-G000-332 (NCT01393743) and this current study (E2007-G000-311).
Measure Participants	138	31
0 ng/mL	0.46	0.26
100 ng/mL	0.71	0.50
200 ng/mL	0.74	0.54
300 ng/mL	0.76	0.57
400 ng/mL	0.77	0.58
500 ng/mL	0.78	0.59
600 ng/mL	0.79	0.60
700 ng/mL	0.80	0.61
800 ng/mL	0.80	0.62
900 ng/mL	0.80	0.63
1000 ng/mL	0.81	0.63
1200 ng/mL	0.82	0.64
1400 ng/mL	0.82	0.65
1600 ng/mL	0.82	0.66
1800 ng/mL	0.83	0.66
2000 ng/mL	0.83	0.67
2200 ng/mL	0.84	0.67
2400 ng/mL	0.84	0.68

8. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline up to Week 23

Outcome Measure Data

Analysis Population Description

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" signifies participants who were evaluable for this measure.

Arm/Group Title	Perampanel: POS	Perampanel: PGTC Seizures
Arm/Group Description	All participants with POS 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-G000-304 (NCT00699972), E2007-G000-305 (NCT00699582), E2007-G000-306 (NCT00700310), E2007-J000-335 (NCT01618695) and this current study (E2007-G000-311).	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).
Measure Participants	1371	92
Measure Seizure free observations	3974	255
>0 to <500 ng/mL	275	57
500 to <1000 ng/mL	103	67
1000 to <1500 ng/mL	33	11
1500 to 2000 ng/mL	7	4
>2000 ng/mL	0	3

9. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline up to Week 23

Outcome Measure Data

Analysis Population Description

All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 0.5 mg/mL: All Participants
Arm/Group Description	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.
Measure Participants	148
Mean (Standard Deviation) [score on a scale]	NA (NA)

10. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline up to Week 23

Outcome Measure Data

Analysis Population Description

All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 0.5 mg/mL: All Participants
Arm/Group Description	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.
Measure Participants	19
Mean (Standard Deviation) [score on a scale]	NA (NA)

11. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline up to Week 23

Outcome Measure Data

Analysis Population Description

All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 0.5 mg/mL: All Participants
Arm/Group Description	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.
Measure Participants	115
Mean (Standard Deviation) [score on a scale]	NA (NA)

12. Secondary Outcome

Title	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 Perampanel
Description	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.
Time Frame	Baseline up to Week 23

Outcome Measure Data

Analysis Population Description

All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 0.5 mg/mL: All Participants
Arm/Group Description	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.
Measure Participants	117
Mean (Standard Deviation) [seconds]	NA (NA)

13. Secondary Outcome

Title	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
Description	The Lafayette Grooved Pegboard Test (LGPT) measures visuomotor skills. This test is a manipulative dexterity test that consist of a metal matrix of 25 holes with randomly positioned slots. Participants require to insert 10 grooved pegs into the holes. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task is timed and the scores are the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds are recorded for the time. An increase in score (longer time) indicate worsening of visuomotor skills. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in Total Time to Complete LGPT Score for Non-dominant Hand could be discerned.
Time Frame	Baseline up to Week 23

Outcome Measure Data

Analysis Population Description

All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 0.5 mg/mL: All Participants
Arm/Group Description	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.
Measure Participants	113
Mean (Standard Deviation) [seconds]	NA (NA)

14. Secondary Outcome

Title	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
Time Frame	Baseline up to 23 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: All Participants
Arm/Group Description	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.
Measure Participants	180
Irritability/Aggression/Agitation	12.8 8.6%
Nasopharyngitis	14.7 9.9%
Influenza	6.4 4.3%
Pyrexia	9.0 6%
Somnolence	13.5 9.1%

15. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline, Week 23, Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	149	31
Baseline	17.7 (18.96)	28.6 (21.01)
Change from Baseline at Week 23	-1.2 (12.77)	3.3 (12.42)
Change from Baseline at Week 52	-3.9 (16.91)	-0.2 (14.67)

16. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline, Week 23, Week 52

Outcome Measure Data

Analysis Population Description

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" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	24	2
Baseline	35.0 (28.30)	54.0 (21.21)
Change from Baseline at Week 23	-0.3 (14.71)	-13.0 (NA)
Change from Baseline at Week 52	-5.7 (14.36)	-11.0 (NA)

17. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline, Week 23, Week 52

Outcome Measure Data

Analysis Population Description

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" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	123	28
Baseline	33.3 (22.66)	44.6 (26.16)
Change from Baseline at Week 23	-0.6 (12.26)	-2.2 (22.84)
Change from Baseline at Week 52	-1.7 (14.51)	-0.7 (16.36)

18. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline, Week 23, Week 52

Outcome Measure Data

Analysis Population Description

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" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	51	10
Dominant Hand: Baseline	196.4 (113.12)	155.0 (108.10)
Dominant Hand: Change from Baseline at Week 23	12.8 (49.37)	-4.3 (3.79)
Dominant Hand: Change from Baseline at Week 52	3.9 (50.50)	13.4 (33.72)
Non Dominant Hand: Baseline	224.3 (108.19)	169.6 (106.49)
Non Dominant Hand: Change from Baseline at Week 23	3.3 (39.59)	-4.3 (14.98)
Non Dominant Hand: Change from Baseline at Week 52	2.6 (46.88)	3.4 (29.35)

19. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline, Week 23, Week 52

Outcome Measure Data

Analysis Population Description

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" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	63	11
Dominant Hand: Baseline	189.8 (103.58)	150.7 (99.68)
Dominant Hand: Change from Baseline at Week 23	0.1 (21.77)	-11.8 (35.05)
Dominant Hand: Change from Baseline at Week 52	3.0 (21.24)	-15.4 (30.43)
Non Dominant Hand: Baseline	197.4 (100.01)	159.9 (84.66)
Non Dominant Hand: Change from Baseline at Week 23	7.8 (36.03)	-7.0 (21.98)
Non Dominant Hand: Change from Baseline at Week 52	2.7 (23.75)	-28.7 (36.15)

20. Secondary Outcome

Title	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
Time Frame	Baseline, Week 23, Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	149	31
Baseline	126.65 (14.293)	131.08 (13.311)
Change from Baseline at Week 23	2.57 (1.926)	1.84 (1.111)
Change from Baseline at Week 52	5.97 (2.580)	5.82 (2.544)

21. Secondary Outcome

Title	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
Time Frame	Baseline, Week 23, Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	149	31
Baseline	28.09 (10.649)	30.43 (11.299)
Change from Baseline at Week 23	1.86 (2.570)	1.70 (3.149)
Change from Baseline at Week 52	3.75 (4.421)	3.74 (4.204)

22. Secondary Outcome

Title	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
Description	Thyrotropin level was measured in milli-international units per liter (mIU/L).
Time Frame	Baseline, Week 23, Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	149	31
Baseline	2.682 (1.5897)	3.080 (2.2919)
Change from Baseline at Week 23	0.141 (1.0523)	-0.519 (1.4828)
Change from Baseline at Week 52	0.112 (1.2559)	-0.632 (1.5632)

23. Secondary Outcome

Title	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
Time Frame	Baseline, Week 23, Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	149	31
Thyroxine, free: Baseline	15.29 (3.993)	15.37 (2.160)
Thyroxine, free: Change at Week 23	-0.07 (4.107)	-0.38 (2.088)
Thyroxine, free: Change at Week 52	0.10 (3.868)	0.08 (2.968)
Triiodothyronine, free: Baseline	5.96 (1.061)	6.10 (0.812)
Triiodothyronine, free: Change at Week 23	0.06 (0.915)	-0.16 (0.699)
Triiodothyronine, free: Change at Week 52	0.04 (0.987)	-0.04 (1.107)

24. Secondary Outcome

Title	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
Time Frame	Baseline, Week 23, Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	149	31
Baseline	24.2 (14.83)	25.9 (13.91)
Change from Baseline at Week 23	1.6 (8.96)	0.6 (7.25)
Change from Baseline at Week 52	6.5 (9.01)	5.1 (8.02)

25. Secondary Outcome

Title	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
Time Frame	Baseline up to 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: All Participants
Arm/Group Description	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.
Measure Participants	180
Number [percentage of participants]	0 0%

26. Secondary Outcome

Title	Number of Encephalogram (EEG) Abnormalities During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study
Time Frame	Baseline up to 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: All Participants
Arm/Group Description	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.
Measure Participants	180
Number [EEG abnormality]	0

27. Secondary Outcome

Title	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
Description	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"). Here, percentage of participants with >=1 positive behavior, participants with >=1 positive ideations, and suicidality were reported. An assessment of SI and behavior using the C-SSRS was performed for participants >=6 years at the time of consent.
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

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" signifies participants who were evaluable for this measure.

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	122	27
Participants with >=1 Positive Behavior	0.8 0.5%	0 0%
Participants with >= Positive Ideations	1.6 1.1%	7.4 23.9%
Suicidality	1.6 1.1%	7.4 23.9%

28. Secondary Outcome

Title	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
Description	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"
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

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" signifies participants who were evaluable for this measure.

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	122	27
No Ideation (Baseline) to No Ideation(Week 52)	96.6 64.8%	88.9 286.8%
Wish to be Dead(Baseline) to No ideation(Week 52)	0.9 0.6%	3.7 11.9%
Active w/ Method(Baseline) to No Ideation(Week 52)	0.9 0.6%	0 0%
No Ideation(Baseline)to Active Nonspecific(Week52)	0 0%	3.7 11.9%
No Ideation(Baseline) to Active w/ Method(Week 52	0.9 0.6%	3.7 11.9%
No Ideation(Baseline)to Active w/ Intent&Plan(W52)	0.9 0.6%	0 0%

29. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.

Arm/Group Title	Perampanel 0.5 mg/mL: 4 to <7 Years	Perampanel 0.5 mg/mL: 7 to <12 Years
Arm/Group Description	Core Phase: Participants of age 4 to <7 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any 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 Phase: Participants of age 7 to <12 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
Measure Participants	46	134
Total POS Seizures: Weeks 1-13	-47.99	-40.97
Total POS Seizures: Weeks 14-26	-38.93	-50.77
Total POS Seizures: Weeks 27-39	-52.53	-67.30
Total POS Seizures: Weeks 40-52	-58.92	-70.33
PGTC Seizures: Weeks 1-13	-100.00	-70.33
PGTC Seizures: Weeks 14-26	-100.00	-70.70
PGTC Seizures: Weeks 27-39	-80.77	-65.43
PGTC Seizures: Weeks 40-52	-100.00	-96.54

30. Secondary Outcome

Title	Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study
Description	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.
Time Frame	Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: 4 to <7 Years	Perampanel 0.5 mg/mL: 7 to <12 Years
Arm/Group Description	Core Phase: Participants of age 4 to <7 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any 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 Phase: Participants of age 7 to <12 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
Measure Participants	46	134
Total POS Seizures: Weeks 1-13	67.5 45.3%	61.1 197.1%
Total POS Seizures: Weeks 14-26	57.9 38.9%	71.4 230.3%
Total POS Seizures: Weeks 27-39	71.9 48.3%	78.0 251.6%
Total POS Seizures: Weeks 40-52	71.0 47.7%	81.8 263.9%
PGTC Seizures: Weeks 1-13	66.7 44.8%	73.7 237.7%
PGTC Seizures: Weeks 14-26	66.7 44.8%	73.3 236.5%
PGTC Seizures: Weeks 27-39	100.0 67.1%	69.2 223.2%
PGTC Seizures: Weeks 40-52	100.0 67.1%	63.6 205.2%

31. Secondary Outcome

Title	Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study
Description	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.
Time Frame	Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: 4 to <7 Years	Perampanel 0.5 mg/mL: 7 to <12 Years
Arm/Group Description	Core Phase: Participants of age 4 to <7 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any 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 Phase: Participants of age 7 to <12 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
Measure Participants	46	134
Total POS Seizures: Weeks 1-13	47.5 31.9%	45.4 146.5%
Total POS Seizures: Weeks 14-26	44.7 30%	50.5 162.9%
Total POS Seizures: Weeks 27-39	53.1 35.6%	65.9 212.6%
Total POS Seizures: Weeks 40-52	61.3 41.1%	62.3 201%
PGTC Seizures: Weeks 1-13	66.7 44.8%	57.9 186.8%
PGTC Seizures: Weeks 14-26	66.7 44.8%	60.0 193.5%
PGTC Seizures: Weeks 27-39	100.0 67.1%	61.5 198.4%
PGTC Seizures: Weeks 40-52	100.0 67.1%	54.5 175.8%

32. Secondary Outcome

Title	Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study
Description	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.
Time Frame	Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: 4 to <7 Years	Perampanel 0.5 mg/mL: 7 to <12 Years
Arm/Group Description	Core Phase: Participants of age 4 to <7 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any 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 Phase: Participants of age 7 to <12 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
Measure Participants	46	134
Total POS Seizures: Weeks 1-13	17.5 11.7%	25.0 80.6%
Total POS Seizures: Weeks 14-26	18.4 12.3%	34.1 110%
Total POS Seizures: Weeks 27-39	31.3 21%	46.3 149.4%
Total POS Seizures: Weeks 40-52	38.7 26%	41.6 134.2%
PGTC Seizures: Weeks 1-13	66.7 44.8%	47.4 152.9%
PGTC Seizures: Weeks 14-26	66.7 44.8%	46.7 150.6%
PGTC Seizures: Weeks 27-39	50.0 33.6%	46.2 149%
PGTC Seizures: Weeks 40-52	100.0 67.1%	54.5 175.8%

33. Secondary Outcome

Title	Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study
Description	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.
Time Frame	Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: 4 to <7 Years	Perampanel 0.5 mg/mL: 7 to <12 Years
Arm/Group Description	Core Phase: Participants of age 4 to <7 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any 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 Phase: Participants of age 7 to <12 years with POS or PGTC seizures received perampanel 0.5 mg/mL oral suspension titrated beyond 8 mg/day up to 12 mg/day, if 8 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are not taking any other EIAED), or titrated beyond 12 mg/day up to 16 mg/day, if 12 mg/day was tolerable and were deemed likely to be benefitted by higher dose (for participants who are taking any EIAED). Dose titration- up to 11 weeks to identify each participant's optimum dose. Participants then continued to take perampanel oral suspension once daily at the optimal dose level as a maintenance dose for up to 12 weeks. Extension Phase A: Participants who completed the Core Phase, entered the Extension Phase A, and continued with their optimal perampanel dose from Core Phase for up to 29 weeks. Total duration of treatment for Core Phase and Extension Phase A was up to 52 weeks.
Measure Participants	46	134
Total POS Seizures: Weeks 1-13	7.9 5.3%	9.9 31.9%
Total POS Seizures: Weeks 14-26	9.4 6.3%	15.9 51.3%
Total POS Seizures: Weeks 27-39	12.9 8.7%	24.7 79.7%
Total POS Seizures: Weeks 40-52	15.0 10.1%	20.8 67.1%
PGTC Seizures: Weeks 1-13	66.7 44.8%	40.0 129%
PGTC Seizures: Weeks 14-26	50.0 33.6%	46.2 149%
PGTC Seizures: Weeks 27-39	50.0 33.6%	45.5 146.8%
PGTC Seizures: Weeks 40-52	100.0 67.1%	57.1 184.2%

34. Secondary Outcome

Title	Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study
Description	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.
Time Frame	Baseline, Week 23, Week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Perampanel 0.5 mg/mL: POS	Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
Measure Participants	149	31
Week 23: Very much improved	11.5 7.7%	8.7 28.1%
Week 23: Much improved	31.1 20.9%	26.1 84.2%
Week 23: Minimally improved	38.5 25.8%	26.1 84.2%
Week 23: No change	14.8 9.9%	26.1 84.2%
Week 23: Minimally worse	3.3 2.2%	13.0 41.9%
Week 23: Much worse	0.8 0.5%	0 0%
Week 52: Very much improved	14.4 9.7%	5.9 19%
Week 52: Much improved	39.4 26.4%	41.2 132.9%
Week 52: Minimally improved	35.6 23.9%	29.4 94.8%
Week 52: No change	7.7 5.2%	17.6 56.8%
Week 52: Minimally worse	1.9 1.3%	5.9 19%
Week 52: Much worse	1.0 0.7%	0 0%

Adverse Events

Time Frame	From baseline up to 56 weeks
Adverse Event Reporting Description	SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Arm/Group Title	Perampanel 0.5 mg/mL: POS		Perampanel 0.5 mg/mL: PGTC Seizures
Arm/Group Description	Core Phase: Participants with 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 Phase: Participants with 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.
All Cause Mortality
	Perampanel 0.5 mg/mL: POS		Perampanel 0.5 mg/mL: PGTC Seizures
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/149 (0.7%)		0/31 (0%)
Serious Adverse Events
	Perampanel 0.5 mg/mL: POS		Perampanel 0.5 mg/mL: PGTC Seizures
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/149 (19.5%)		7/31 (22.6%)
Gastrointestinal disorders
Dental caries	1/149 (0.7%)		0/31 (0%)
Gastritis erosive	1/149 (0.7%)		0/31 (0%)
Constipation	1/149 (0.7%)		0/31 (0%)
Gastrooesophageal reflux disease	1/149 (0.7%)		0/31 (0%)
Vomiting	1/149 (0.7%)		1/31 (3.2%)
General disorders
Gait disturbance	1/149 (0.7%)		0/31 (0%)
Hyperthermia	1/149 (0.7%)		0/31 (0%)
Infections and infestations
Bronchitis	3/149 (2%)		0/31 (0%)
Encephalitis	1/149 (0.7%)		0/31 (0%)
Gastroenteritis	2/149 (1.3%)		0/31 (0%)
Influenza	3/149 (2%)		0/31 (0%)
Pneumonia	4/149 (2.7%)		0/31 (0%)
Rhinovirus infection	0/149 (0%)		1/31 (3.2%)
Urinary tract infection pseudomonal	1/149 (0.7%)		0/31 (0%)
Viral infection	0/149 (0%)		1/31 (3.2%)
Viral myocarditis	1/149 (0.7%)		0/31 (0%)
Bronchiolitis	1/149 (0.7%)		0/31 (0%)
Pyelonephritis acute	1/149 (0.7%)		0/31 (0%)
Upper respiratory tract infection	1/149 (0.7%)		0/31 (0%)
Metabolism and nutrition disorders
Dehydration	1/149 (0.7%)		0/31 (0%)
Musculoskeletal and connective tissue disorders
Epiphysiolysis	1/149 (0.7%)		0/31 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of testis	1/149 (0.7%)		0/31 (0%)
Cerebral haemangioma	1/149 (0.7%)		0/31 (0%)
Nervous system disorders
Ataxia	1/149 (0.7%)		0/31 (0%)
Dysarthria	1/149 (0.7%)		0/31 (0%)
Epilepsy	2/149 (1.3%)		1/31 (3.2%)
Focal dyscognitive seizures	1/149 (0.7%)		0/31 (0%)
Generalised tonic-clonic seizure	1/149 (0.7%)		1/31 (3.2%)
Petit mal epilepsy	1/149 (0.7%)		1/31 (3.2%)
Rasmussen encephalitis	1/149 (0.7%)		0/31 (0%)
Seizure	2/149 (1.3%)		3/31 (9.7%)
Seizure cluster	1/149 (0.7%)		1/31 (3.2%)
Somnolence	1/149 (0.7%)		1/31 (3.2%)
Product Issues
Device malfunction	1/149 (0.7%)		0/31 (0%)
Psychiatric disorders
Aggression	1/149 (0.7%)		0/31 (0%)
Disruptive mood dysregulation disorder	1/149 (0.7%)		0/31 (0%)
Hallucination, visual	1/149 (0.7%)		0/31 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	2/149 (1.3%)		0/31 (0%)
Asthma	1/149 (0.7%)		0/31 (0%)
Atelectasis	1/149 (0.7%)		0/31 (0%)
Upper respiratory tract inflammation	1/149 (0.7%)		0/31 (0%)
Respiratory distress	1/149 (0.7%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Perampanel 0.5 mg/mL: POS		Perampanel 0.5 mg/mL: PGTC Seizures
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	135/149 (90.6%)		25/31 (80.6%)
Blood and lymphatic system disorders
Anaemia	2/149 (1.3%)		0/31 (0%)
Increased tendency to bruise	1/149 (0.7%)		0/31 (0%)
Thrombocytopenia	1/149 (0.7%)		0/31 (0%)
Iron deficiency anaemia	2/149 (1.3%)		0/31 (0%)
Macrocytosis	1/149 (0.7%)		0/31 (0%)
Neutropenia	2/149 (1.3%)		0/31 (0%)
Ear and labyrinth disorders
Ear pain	1/149 (0.7%)		0/31 (0%)
Tympanic membrane perforation	1/149 (0.7%)		0/31 (0%)
Vertigo	2/149 (1.3%)		3/31 (9.7%)
Eye disorders
Conjunctivitis allergic	2/149 (1.3%)		0/31 (0%)
Corneal disorder	1/149 (0.7%)		0/31 (0%)
Diplopia	3/149 (2%)		1/31 (3.2%)
Mydriasis	0/149 (0%)		1/31 (3.2%)
Vision blurred	1/149 (0.7%)		0/31 (0%)
Conjunctival hyperaemia	1/149 (0.7%)		0/31 (0%)
Keratitis	1/149 (0.7%)		0/31 (0%)
Strabismus	0/149 (0%)		1/31 (3.2%)
Gastrointestinal disorders
Abdominal discomfort	0/149 (0%)		1/31 (3.2%)
Abdominal pain	3/149 (2%)		2/31 (6.5%)
Abdominal pain upper	2/149 (1.3%)		0/31 (0%)
Anal incontinence	0/149 (0%)		1/31 (3.2%)
Constipation	5/149 (3.4%)		3/31 (9.7%)
Diarrhoea	9/149 (6%)		3/31 (9.7%)
Dry mouth	1/149 (0.7%)		0/31 (0%)
Dysphagia	1/149 (0.7%)		0/31 (0%)
Enteritis	1/149 (0.7%)		0/31 (0%)
Erosive oesophagitis	1/149 (0.7%)		0/31 (0%)
Gastrooesophageal reflux disease	2/149 (1.3%)		0/31 (0%)
Haematemesis	1/149 (0.7%)		0/31 (0%)
Nausea	3/149 (2%)		1/31 (3.2%)
Odynophagia	1/149 (0.7%)		0/31 (0%)
Salivary hypersecretion	4/149 (2.7%)		0/31 (0%)
Stomatitis	3/149 (2%)		0/31 (0%)
Toothache	3/149 (2%)		1/31 (3.2%)
Vomiting	20/149 (13.4%)		5/31 (16.1%)
Dental caries	1/149 (0.7%)		0/31 (0%)
Functional gastrointestinal disorder	1/149 (0.7%)		0/31 (0%)
Ranula	1/149 (0.7%)		0/31 (0%)
General disorders
Asthenia	1/149 (0.7%)		1/31 (3.2%)
Crying	1/149 (0.7%)		0/31 (0%)
Fatigue	9/149 (6%)		2/31 (6.5%)
Gait disturbance	7/149 (4.7%)		0/31 (0%)
Influenza like illness	0/149 (0%)		1/31 (3.2%)
Pain	1/149 (0.7%)		0/31 (0%)
Pyrexia	25/149 (16.8%)		4/31 (12.9%)
Medical device pain	1/149 (0.7%)		0/31 (0%)
Screaming	0/149 (0%)		1/31 (3.2%)
Immune system disorders
Rubber sensitivity	1/149 (0.7%)		0/31 (0%)
Seasonal allergy	1/149 (0.7%)		0/31 (0%)
Infections and infestations
Acute sinusitis	2/149 (1.3%)		0/31 (0%)
Beta haemolytic streptococcal infection	0/149 (0%)		1/31 (3.2%)
Bronchitis	10/149 (6.7%)		0/31 (0%)
Conjunctivitis	5/149 (3.4%)		1/31 (3.2%)
Ear infection	3/149 (2%)		2/31 (6.5%)
Enterocolitis viral	1/149 (0.7%)		0/31 (0%)
Fungal infection	0/149 (0%)		1/31 (3.2%)
Fungal skin infection	1/149 (0.7%)		0/31 (0%)
Gastroenteritis	11/149 (7.4%)		2/31 (6.5%)
Hordeolum	3/149 (2%)		0/31 (0%)
Influenza	20/149 (13.4%)		0/31 (0%)
Lymphangitis	1/149 (0.7%)		0/31 (0%)
Nasopharyngitis	40/149 (26.8%)		3/31 (9.7%)
Oral herpes	2/149 (1.3%)		0/31 (0%)
Otitis externa	1/149 (0.7%)		0/31 (0%)
Otitis media	1/149 (0.7%)		0/31 (0%)
Otitis media acute	1/149 (0.7%)		1/31 (3.2%)
Paronychia	1/149 (0.7%)		0/31 (0%)
Pharyngitis	6/149 (4%)		0/31 (0%)
Pharyngitis streptococcal	2/149 (1.3%)		1/31 (3.2%)
Pneumonia	1/149 (0.7%)		0/31 (0%)
Respiratory tract infection	2/149 (1.3%)		0/31 (0%)
Respiratory tract infection viral	1/149 (0.7%)		0/31 (0%)
Rhinitis	5/149 (3.4%)		3/31 (9.7%)
Sinusitis	1/149 (0.7%)		1/31 (3.2%)
Streptococcal infection	1/149 (0.7%)		0/31 (0%)
Tonsillitis	1/149 (0.7%)		1/31 (3.2%)
Upper respiratory tract infection	15/149 (10.1%)		3/31 (9.7%)
Urinary tract infection	5/149 (3.4%)		0/31 (0%)
Viral infection	4/149 (2.7%)		0/31 (0%)
Viral rash	1/149 (0.7%)		0/31 (0%)
Viral upper respiratory tract infection	1/149 (0.7%)		1/31 (3.2%)
Croup infectious	0/149 (0%)		1/31 (3.2%)
Gastroenteritis viral	1/149 (0.7%)		0/31 (0%)
Herpes zoster	1/149 (0.7%)		0/31 (0%)
Impetigo	1/149 (0.7%)		0/31 (0%)
Oral fungal infection	1/149 (0.7%)		0/31 (0%)
Perianal streptococcal infection	1/149 (0.7%)		0/31 (0%)
Tinea pedis	1/149 (0.7%)		0/31 (0%)
Varicella	1/149 (0.7%)		0/31 (0%)
Injury, poisoning and procedural complications
Accidental overdose	1/149 (0.7%)		1/31 (3.2%)
Animal bite	2/149 (1.3%)		0/31 (0%)
Arthropod sting	1/149 (0.7%)		0/31 (0%)
Contusion	6/149 (4%)		1/31 (3.2%)
Eye contusion	1/149 (0.7%)		0/31 (0%)
Eye injury	1/149 (0.7%)		0/31 (0%)
Fall	2/149 (1.3%)		3/31 (9.7%)
Foot fracture	1/149 (0.7%)		0/31 (0%)
Forearm fracture	1/149 (0.7%)		0/31 (0%)
Head injury	1/149 (0.7%)		0/31 (0%)
Joint injury	1/149 (0.7%)		0/31 (0%)
Laceration	3/149 (2%)		3/31 (9.7%)
Ligament sprain	2/149 (1.3%)		0/31 (0%)
Limb injury	0/149 (0%)		1/31 (3.2%)
Mallet finger	1/149 (0.7%)		0/31 (0%)
Nail avulsion	0/149 (0%)		1/31 (3.2%)
Scar	0/149 (0%)		1/31 (3.2%)
Seroma	0/149 (0%)		1/31 (3.2%)
Skin abrasion	3/149 (2%)		0/31 (0%)
Thermal burn	1/149 (0.7%)		0/31 (0%)
Wound	1/149 (0.7%)		0/31 (0%)
Wrist fracture	1/149 (0.7%)		0/31 (0%)
Clavicle fracture	1/149 (0.7%)		0/31 (0%)
Heat stroke	1/149 (0.7%)		0/31 (0%)
Joint dislocation	1/149 (0.7%)		0/31 (0%)
Stoma site hypergranulation	1/149 (0.7%)		0/31 (0%)
Traumatic haematoma	1/149 (0.7%)		0/31 (0%)
Investigations
Body temperature increased	1/149 (0.7%)		0/31 (0%)
Urine output decreased	1/149 (0.7%)		0/31 (0%)
Weight decreased	3/149 (2%)		1/31 (3.2%)
Weight increased	6/149 (4%)		2/31 (6.5%)
Alanine aminotransferase increased	1/149 (0.7%)		0/31 (0%)
Aspartate aminotransferase increased	1/149 (0.7%)		0/31 (0%)
Blood pressure systolic increased	1/149 (0.7%)		0/31 (0%)
Blood uric acid increased	1/149 (0.7%)		0/31 (0%)
Crystal urine present	0/149 (0%)		1/31 (3.2%)
Eosinophil count increased	1/149 (0.7%)		0/31 (0%)
Tri-iodothyronine free increased	0/149 (0%)		1/31 (3.2%)
White blood cells urine positive	1/149 (0.7%)		0/31 (0%)
Metabolism and nutrition disorders
Decreased appetite	2/149 (1.3%)		4/31 (12.9%)
Hyperuricaemia	1/149 (0.7%)		0/31 (0%)
Increased appetite	6/149 (4%)		1/31 (3.2%)
Polydipsia	0/149 (0%)		1/31 (3.2%)
Dehydration	1/149 (0.7%)		0/31 (0%)
Hypoglycaemia	1/149 (0.7%)		0/31 (0%)
Hyponatraemia	1/149 (0.7%)		0/31 (0%)
Hypophosphataemia	1/149 (0.7%)		0/31 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/149 (0.7%)		0/31 (0%)
Kyphosis	0/149 (0%)		1/31 (3.2%)
Muscle rigidity	0/149 (0%)		1/31 (3.2%)
Muscle spasms	1/149 (0.7%)		0/31 (0%)
Pain in extremity	0/149 (0%)		1/31 (3.2%)
Periosteal haematoma	1/149 (0.7%)		0/31 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	1/149 (0.7%)		0/31 (0%)
Nervous system disorders
Amnesia	1/149 (0.7%)		1/31 (3.2%)
Ataxia	6/149 (4%)		2/31 (6.5%)
Atonic seizures	0/149 (0%)		1/31 (3.2%)
Balance disorder	4/149 (2.7%)		3/31 (9.7%)
Cerebral haematoma	0/149 (0%)		1/31 (3.2%)
Clumsiness	1/149 (0.7%)		0/31 (0%)
Cognitive disorder	1/149 (0.7%)		1/31 (3.2%)
Coordination abnormal	1/149 (0.7%)		0/31 (0%)
Disturbance in attention	5/149 (3.4%)		1/31 (3.2%)
Dizziness	19/149 (12.8%)		5/31 (16.1%)
Drooling	4/149 (2.7%)		0/31 (0%)
Dysarthria	2/149 (1.3%)		2/31 (6.5%)
Dyslexia	1/149 (0.7%)		0/31 (0%)
Dysstasia	1/149 (0.7%)		0/31 (0%)
Focal dyscognitive seizures	1/149 (0.7%)		0/31 (0%)
Headache	10/149 (6.7%)		5/31 (16.1%)
Hypotonia	2/149 (1.3%)		0/31 (0%)
Lethargy	1/149 (0.7%)		1/31 (3.2%)
Memory impairment	3/149 (2%)		2/31 (6.5%)
Motor dysfunction	2/149 (1.3%)		1/31 (3.2%)
Nystagmus	1/149 (0.7%)		0/31 (0%)
Persistent postural-perceptual dizziness	1/149 (0.7%)		0/31 (0%)
Petit mal epilepsy	1/149 (0.7%)		1/31 (3.2%)
Postictal state	1/149 (0.7%)		0/31 (0%)
Psychomotor hyperactivity	5/149 (3.4%)		2/31 (6.5%)
Psychomotor skills impaired	1/149 (0.7%)		0/31 (0%)
Sedation	0/149 (0%)		1/31 (3.2%)
Seizure	6/149 (4%)		3/31 (9.7%)
Somnolence	43/149 (28.9%)		5/31 (16.1%)
Status epilepticus	2/149 (1.3%)		0/31 (0%)
Epilepsy	1/149 (0.7%)		0/31 (0%)
Hippocampal sclerosis	0/149 (0%)		1/31 (3.2%)
Migraine	1/149 (0.7%)		0/31 (0%)
Poor quality sleep	0/149 (0%)		1/31 (3.2%)
Seizure cluster	1/149 (0.7%)		0/31 (0%)
Simple partial seizures	2/149 (1.3%)		0/31 (0%)
Tremor	1/149 (0.7%)		0/31 (0%)
Psychiatric disorders
Abnormal behaviour	0/149 (0%)		1/31 (3.2%)
Adjustment disorder	1/149 (0.7%)		0/31 (0%)
Affect lability	1/149 (0.7%)		0/31 (0%)
Aggression	15/149 (10.1%)		2/31 (6.5%)
Agitation	7/149 (4.7%)		2/31 (6.5%)
Anger	3/149 (2%)		0/31 (0%)
Anxiety	3/149 (2%)		2/31 (6.5%)
Attention deficit/hyperactivity disorder	4/149 (2.7%)		0/31 (0%)
Bradyphrenia	5/149 (3.4%)		0/31 (0%)
Defiant behaviour	1/149 (0.7%)		0/31 (0%)
Dysphemia	1/149 (0.7%)		1/31 (3.2%)
Dysphoria	1/149 (0.7%)		0/31 (0%)
Enuresis	3/149 (2%)		0/31 (0%)
Euphoric mood	0/149 (0%)		1/31 (3.2%)
Hypervigilance	0/149 (0%)		1/31 (3.2%)
Insomnia	5/149 (3.4%)		1/31 (3.2%)
Irritability	19/149 (12.8%)		5/31 (16.1%)
Learning disability	1/149 (0.7%)		0/31 (0%)
Middle insomnia	1/149 (0.7%)		0/31 (0%)
Mood altered	1/149 (0.7%)		0/31 (0%)
Negativism	1/149 (0.7%)		0/31 (0%)
Nightmare	0/149 (0%)		1/31 (3.2%)
Oppositional defiant disorder	1/149 (0.7%)		0/31 (0%)
Personality change	0/149 (0%)		1/31 (3.2%)
Restlessness	2/149 (1.3%)		0/31 (0%)
Sleep disorder	3/149 (2%)		0/31 (0%)
Somnambulism	1/149 (0.7%)		0/31 (0%)
Suicidal ideation	0/149 (0%)		1/31 (3.2%)
Tic	1/149 (0.7%)		0/31 (0%)
Distractibility	0/149 (0%)		1/31 (3.2%)
Initial insomnia	1/149 (0.7%)		0/31 (0%)
Renal and urinary disorders
Polyuria	0/149 (0%)		1/31 (3.2%)
Urinary incontinence	4/149 (2.7%)		2/31 (6.5%)
Haematuria	1/149 (0.7%)		0/31 (0%)
Hypertonic bladder	1/149 (0.7%)		0/31 (0%)
Pollakiuria	1/149 (0.7%)		0/31 (0%)
Proteinuria	1/149 (0.7%)		0/31 (0%)
Vesicoureteric reflux	1/149 (0.7%)		0/31 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/149 (0.7%)		0/31 (0%)
Cough	4/149 (2.7%)		2/31 (6.5%)
Epistaxis	5/149 (3.4%)		3/31 (9.7%)
Increased upper airway secretion	1/149 (0.7%)		0/31 (0%)
Lower respiratory tract congestion	1/149 (0.7%)		0/31 (0%)
Nasal congestion	1/149 (0.7%)		2/31 (6.5%)
Oropharyngeal pain	4/149 (2.7%)		0/31 (0%)
Productive cough	1/149 (0.7%)		0/31 (0%)
Rhinitis allergic	1/149 (0.7%)		0/31 (0%)
Rhinorrhoea	4/149 (2.7%)		2/31 (6.5%)
Upper respiratory tract inflammation	4/149 (2.7%)		0/31 (0%)
Respiratory disorder	1/149 (0.7%)		0/31 (0%)
Sleep apnoea syndrome	1/149 (0.7%)		0/31 (0%)
Upper airway obstruction	2/149 (1.3%)		0/31 (0%)
Skin and subcutaneous tissue disorders
Acne	2/149 (1.3%)		1/31 (3.2%)
Alopecia	1/149 (0.7%)		1/31 (3.2%)
Dermatitis	1/149 (0.7%)		0/31 (0%)
Dermatitis contact	4/149 (2.7%)		0/31 (0%)
Dermatitis diaper	1/149 (0.7%)		0/31 (0%)
Drug eruption	1/149 (0.7%)		0/31 (0%)
Eczema	2/149 (1.3%)		1/31 (3.2%)
Erythema	1/149 (0.7%)		0/31 (0%)
Mechanical urticaria	1/149 (0.7%)		0/31 (0%)
Miliaria	2/149 (1.3%)		0/31 (0%)
Rash	6/149 (4%)		1/31 (3.2%)
Rash erythematous	0/149 (0%)		1/31 (3.2%)
Rash morbilliform	1/149 (0.7%)		0/31 (0%)
Rash papular	1/149 (0.7%)		0/31 (0%)
Skin hyperpigmentation	0/149 (0%)		1/31 (3.2%)
Urticaria	4/149 (2.7%)		0/31 (0%)
Angioedema	1/149 (0.7%)		0/31 (0%)
Dermatitis atopic	1/149 (0.7%)		0/31 (0%)
Rash generalised	1/149 (0.7%)		0/31 (0%)
Rash maculo-papular	1/149 (0.7%)		0/31 (0%)
Skin erosion	1/149 (0.7%)		0/31 (0%)
Vascular disorders
Peripheral coldness	1/149 (0.7%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.