Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures

• Sponsor: Eisai Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03288129
• Collaborator: (none)
• Enrollment: 54
• Locations: 24
• Arm: 1
• Actual Duration (Months): 44.1
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study will assess the retention rate of perampanel when given as monotherapy or first adjunctive therapy in participants with partial-onset seizures or primary generalized tonic clonic seizures. The study consists of 4 periods: a Screening Period (to start no earlier than 6 weeks before the first dose of study drug), a Titration Period (up to 13 weeks), a Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).

Condition or Disease	Intervention/Treatment	Phase
Partial Onset Seizures; Secondarily Generalized Seizures; Primary Generalized Tonic-Clonic Seizures	Drug: Perampanel	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures
• Actual Study Start Date: Aug 23, 2017
• Actual Primary Completion Date: Apr 27, 2021
• Actual Study Completion Date: Apr 27, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Perampanel Perampanel will be administered orally once daily (QD) at bedtime. At the beginning of the Titration Period, oral perampanel will start at a dose of 2 milligrams (mg) QD. Doses of perampanel will then be up titrated in increments of 2 mg at no less than 2-week intervals according to the investigator's judgment. At the 4 mg dose, the investigator will confirm whether further dose escalation is needed based on participant response and tolerability. The investigator may adjust dosing further or leave the participant at 4 mg. The maximum dose is 12 mg. During the 39-week Maintenance Period, participants will continue to receive the perampanel dose level that was administered at the end of the Titration Period.

Drug: Perampanel; film-coated tablets; Other Names: Fycompa E2007

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment [Month 3]

   The retention rate was defined as the percentage of participants remaining on perampanel treatment at 3 months after the initiation of treatment.

2. Percentage of Participants Remaining on Perampanel Treatment at 6 Months After the Initiation of Treatment [Month 6]

   The retention rate was defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.

3. Percentage of Participants Remaining on Perampanel Treatment at 9 Months After the Initiation of Treatment [Month 9]

   The retention rate was defined as the percentage of participants remaining on perampanel treatment at 9 months after the initiation of treatment.

4. Percentage of Participants Remaining on Perampanel Treatment at 12 Months After the Initiation of Treatment [Month 12]

   The retention rate was defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.

Secondary Outcome Measures

1. Percentage of Participants Who Achieved Seizure-free Status During the Maintenance Period [Up to 39 weeks of Maintenance Period]

   Seizure-free status was defined as no incidence of seizure during the entire maintenance period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participants does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.

2. Percentage of Participants Who Achieved 3-month Seizure-free Status During the Maintenance Period [Up to 3 months of Maintenance Period]

   Seizure-free status was defined as no incidence of seizure at 3 months during the Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.

3. Percentage of Participants Who Achieved 6-month Seizure-free Status During the Maintenance Period [Up to 6 months of Maintenance Period]

   Seizure-free status was defined as no incidence of seizure at 6 months during Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.

4. Percentage of Participants Who Received Perampanel as a First Adjunctive Therapy and Converted to Perampanel Monotherapy [Up to 52 weeks]

   Percentage of participants who received perampanel as a first adjunctive therapy and converted to perampanel monotherapy were reported.

5. Number of Participants With Treatment-emergent Adverse Events (TEAE) [From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)]

   A TEAE was defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.

6. Number of Participants With Treatment-emergent Serious Adverse Events (SAE) [From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)]

   A SAE was defined as any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect. A TEAE was defined as an event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants will be male or female and no younger than 4 years of age and be able to swallow perampanel tablets.

• Participants must have a diagnosis of epilepsy with POS with or without SGS or with

PGTCS. Either of the following must have occurred to support an epilepsy diagnosis:

1. At least two unprovoked (or reflex) seizures occurring greater than 24 hours apart

2. One unprovoked (or reflex) seizure with Electroencephalography (EEG) evidence of seizures

• Participants who receive perampanel as a first adjunctive therapy must currently have been treated with stable doses of monotherapy with an anti-epileptic drug (AED) for 8 weeks prior to Visit 2 (Week 0), have not previously received adjunctive AED treatment, and must, in the investigator's judgement, be in need of initial adjunctive therapy after failure to control seizures with AED monotherapy, at the optimal dose and duration.

• Participants who receive perampanel as monotherapy, who were newly diagnosed (treatment naïve), following the defined diagnosis of epilepsy.

• Participants who are currently receiving monotherapy treatment may receive perampanel as monotherapy if, in the investigator's judgment, the participant may benefit from a change in monotherapy treatment. Participants must not have previously received adjunctive AED treatment.

• If antidepressants or antianxiety drugs are used, participants must be on a stable dose regimen of these drugs during the 8 weeks before Visit 2 (Week 0).

Exclusion Criteria:

• Participants should not have previously received or currently be receiving perampanel.

• Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [β-hCG] or 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:

• Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:

• Total abstinence (if it is their preferred and usual lifestyle)

• An intrauterine device or intrauterine hormone-releasing system

• An oral contraceptive (with additional barrier method if using contraceptive containing levonorgestrel); participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation

• Have a vasectomized partner with confirmed azoospermia

• Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation For sites outside of the European Union, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, i.e, double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide.

NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).

• Presence of or previous history of Lennox-Gastaut syndrome

• Presence of non-motor simple partial seizures only

• A history of status epilepticus within 1 year before Screening Visit (Visit 1)

• Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Screening Visit (Visit 1)

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

• Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 2 (Week 0)

• Use of intermittent rescue benzodiazepines (i.e, 1 to 2 doses over a 24-hour period is considered a one time rescue) 2 or more times in the 8-week period prior to Visit 2 (Week 0)

• Severe renal insufficiency (defined by estimated glomerular filtration rate of < 30 milliliters per minute [mL/min]) or participants who receive hemodialysis

• Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the participant's safety or study conduct NOTE: Stable elevation of liver enzymes, alanine aminotransferase and aspartate aminotransferase due to concomitant medication(s) will be allowed if they are less than 3 times the upper limits of normal.

• Hypersensitivity to perampanel or any excipients

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

• Participants who are participating in other interventional clinical trial

• Participant who are judged to have inadequate cognitive ability for participation in the study (intelligence quotient < 80 or investigator judgment)

• Any suicidal ideation with intent with or without a plan, at the time of or within 6 months of screening, as indicated by answering "Yes" to questions 4 and 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS)

• Any lifetime suicidal behavior based on the C-SSRS

• Concomitant use of any form of cannabidiol (CBD)

• Planned brain surgery during study participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Barrow Neurological Institute	Phoenix	Arizona	United States	85013
3	Arkansas Epilepsy Program	Little Rock	Arkansas	United States	72205
4	UCSD Epilepsy Center	La Jolla	California	United States	92393
5	Stanford Medical Center	Palo Alto	California	United States	94304
6	UC Davis Medical Center	Sacramento	California	United States	95817
7	Baptist Health, Nemours Children's Specialty Care	Jacksonville	Florida	United States	32207
8	RUSH University Medical Center	Chicago	Illinois	United States	60612
9	University of Kentucky	Lexington	Kentucky	United States	40536
10	Johns Hopkins Medicine	Baltimore	Maryland	United States	21287
11	Mid-Atlantic Epilepsy and Sleep Center	Bethesda	Maryland	United States	20817
12	Tufts Medical Center	Boston	Massachusetts	United States	02111
13	The Regents of The University of Michigan	Ann Arbor	Michigan	United States	48109
14	Michigan State University	East Lansing	Michigan	United States	48824
15	Minneapolis Clinic of Neurology	Golden Valley	Minnesota	United States	55442
16	JFK Medical Center	Edison	New Jersey	United States	08820
17	Northeast Regional Epilepsy Group	Hackensack	New Jersey	United States	07601
18	UNM Health Providers	Albuquerque	New Mexico	United States	87106
19	Mount Sinai Medical Center	New York	New York	United States	10016
20	Duke Neurology	Durham	North Carolina	United States	27710
21	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
22	Cleveland Clinic	Cleveland	Ohio	United States	44195
23	UT Southwestern Medical Center	Dallas	Texas	United States	75390
24	Children's Hospital of San Antonio	San Antonio	Texas	United States	78207

Sponsors and Collaborators

• Eisai Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Apr 12, 2019
• Statistical Analysis Plan - May 17, 2021

More Information

Publications

None provided.

• Responsible Party: Eisai Inc.
• ClinicalTrials.gov Identifier: NCT03288129
• Other Study ID Numbers: E2007-G000-410; 2017-001180-20
• First Posted: Sep 19, 2017
• Last Update Posted: May 16, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eisai Inc.: monotherapy; adjunctive therapy; open-label; multicenter
• Additional relevant MeSH terms: Seizures

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 14 investigative sites in the United States from 23 August 2017 to 27 April 2021.
Pre-assignment Detail	A total of 68 participants were screened, of which 54 were treated with perampanel.

Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 milligrams per day (mg/day) and were up-titrated in no less than 2-week intervals in increments of 2 milligram (mg) up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
Period Title: Overall Study
STARTED	54
COMPLETED	32
NOT COMPLETED	22

Baseline Characteristics

Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
Overall Participants	54
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.5 (17.32)
Sex: Female, Male (Count of Participants)
Female	27 50%
Male	27 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 13%
Not Hispanic or Latino	47 87%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 1.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	9 16.7%
White	42 77.8%
More than one race	0 0%
Unknown or Not Reported	2 3.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment
Description	The retention rate was defined as the percentage of participants remaining on perampanel treatment at 3 months after the initiation of treatment.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
Measure Participants	54
Number [percentage of participants]	85.2 157.8%

2. Primary Outcome

Title	Percentage of Participants Remaining on Perampanel Treatment at 6 Months After the Initiation of Treatment
Description	The retention rate was defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
Measure Participants	54
Number [percentage of participants]	68.5 126.9%

3. Primary Outcome

Title	Percentage of Participants Remaining on Perampanel Treatment at 9 Months After the Initiation of Treatment
Description	The retention rate was defined as the percentage of participants remaining on perampanel treatment at 9 months after the initiation of treatment.
Time Frame	Month 9

Outcome Measure Data

Analysis Population Description

The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
Measure Participants	54
Number [percentage of participants]	63.0 116.7%

4. Primary Outcome

Title	Percentage of Participants Remaining on Perampanel Treatment at 12 Months After the Initiation of Treatment
Description	The retention rate was defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
Measure Participants	54
Number [percentage of participants]	51.9 96.1%

5. Secondary Outcome

Title	Percentage of Participants Who Achieved Seizure-free Status During the Maintenance Period
Description	Seizure-free status was defined as no incidence of seizure during the entire maintenance period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participants does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.
Time Frame	Up to 39 weeks of Maintenance Period

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) included participants who received at least 1 dose of study drug and had at least 1 postdose seizure measurement. Here "overall number of participants analyzed" signifies participants those who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
Measure Participants	52
Number [percentage of participants]	19.2 35.6%

6. Secondary Outcome

Title	Percentage of Participants Who Achieved 3-month Seizure-free Status During the Maintenance Period
Description	Seizure-free status was defined as no incidence of seizure at 3 months during the Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.
Time Frame	Up to 3 months of Maintenance Period

Outcome Measure Data

Analysis Population Description

The FAS included participants who received at least 1 dose of study drug and had at least 1 postdose seizure measurement. Here "overall number of participants analyzed" signifies participants those who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
Measure Participants	52
Number [percentage of participants]	34.6 64.1%

7. Secondary Outcome

Title	Percentage of Participants Who Achieved 6-month Seizure-free Status During the Maintenance Period
Description	Seizure-free status was defined as no incidence of seizure at 6 months during Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.
Time Frame	Up to 6 months of Maintenance Period

Outcome Measure Data

Analysis Population Description

The FAS included participants who received at least 1 dose of study drug and had at least 1 postdose seizure measurement. Here "overall number of participants analyzed" signifies participants those who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
Measure Participants	52
Number [percentage of participants]	23.1 42.8%

8. Secondary Outcome

Title	Percentage of Participants Who Received Perampanel as a First Adjunctive Therapy and Converted to Perampanel Monotherapy
Description	Percentage of participants who received perampanel as a first adjunctive therapy and converted to perampanel monotherapy were reported.
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

The FAS included participants who received at least 1 dose of study drug and had at least 1 postdose seizure measurement. Here "overall number of participants analyzed" signifies participants those who were evaluable for this outcome measure.

Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
Measure Participants	52
Number [percentage of participants]	28.8 53.3%

9. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAE)
Description	A TEAE was defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.
Time Frame	From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)

Outcome Measure Data

Analysis Population Description

The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
Measure Participants	54
Count of Participants [Participants]	48 88.9%

10. Secondary Outcome

Title	Number of Participants With Treatment-emergent Serious Adverse Events (SAE)
Description	A SAE was defined as any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect. A TEAE was defined as an event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.
Time Frame	From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)

Outcome Measure Data

Analysis Population Description

The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
Measure Participants	54
Count of Participants [Participants]	4 7.4%

Adverse Events

Time Frame	From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)
Arm/Group Title	Perampanel 12 mg
Arm/Group Description	During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.
All Cause Mortality
	Perampanel 12 mg
	Affected / at Risk (%)	# Events
Total	1/54 (1.9%)
Serious Adverse Events
	Perampanel 12 mg
	Affected / at Risk (%)	# Events
Total	4/54 (7.4%)
General disorders
Sudden unexplained death in epilepsy	1/54 (1.9%)	1
Nervous system disorders
Transient ischaemic attack	1/54 (1.9%)	1
Psychiatric disorders
Depression	1/54 (1.9%)	1
Mental status changes	1/54 (1.9%)	1
Suicidal ideation	1/54 (1.9%)	1
Other (Not Including Serious) Adverse Events
	Perampanel 12 mg
	Affected / at Risk (%)	# Events
Total	47/54 (87%)
Gastrointestinal disorders
Nausea	4/54 (7.4%)	7
Vomiting	6/54 (11.1%)	6
General disorders
Fatigue	9/54 (16.7%)	12
Infections and infestations
Upper respiratory tract infection	3/54 (5.6%)	4
Nasopharyngitis	5/54 (9.3%)	6
Ear infection	4/54 (7.4%)	5
Nervous system disorders
Balance disorder	3/54 (5.6%)	3
Dizziness	15/54 (27.8%)	19
Headache	5/54 (9.3%)	5
Memory impairment	3/54 (5.6%)	3
Somnolence	8/54 (14.8%)	10
Psychiatric disorders
Aggression	3/54 (5.6%)	3
Depression	3/54 (5.6%)	3
Irritability	5/54 (9.3%)	6
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	3/54 (5.6%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.