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A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

Primary Purpose

Partial-onset Seizures

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Perampanel
Placebo
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial-onset Seizures focused on measuring Partial-onset Seizures, partial seizures, seizure, epilepsy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Male or female and greater than or equal to 12 years of age;
  2. Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures
  3. Participants with computed tomography (CT) or magnetic resonance imaging (MRI) diagnosis within the last 10 years (for adults) and 5 years (for adolescents) prior to visit 1 that ruled out progressive central nervous system (CNS) disorders, example, neurodegenerative disorders, brain tumors. For participants without existing CT or MRI results, CT or MRI was performed at or after Visit 1 but results evaluation was performed by Visit 2
  4. Participants who had been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard antiepileptic drug (AED) for 2 years before enrollment
  5. During the 6-week Prerandomization Phase participants must have had greater than or equal to 5 partial seizures per 6-week
  6. Are currently being treated with stable doses and administrations of 1, 2, or a maximum of 3 approved AEDs. Only 1 inducer AED (defined as carbamazepine, phenytoin or oxcarbazepine only) out of the maximum of 3 AEDs is allowed

Exclusion Criteria

  1. Presence of nonmotor simple partial seizures only;
  2. Presence of primary generalized epilepsies or seizures, such as absences and/or myoclonic epilepsies;
  3. Presence or previous history of Lennox-Gastaut syndrome;
  4. A history of status epilepticus within 1 year prior to screening
  5. Seizure clusters where individual seizures cannot be counted
  6. A history of psychogenic seizures within 5 years prior to screening

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Perampanel

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)
Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness.

Secondary Outcome Measures

Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)
Responder rate was percentage of participants with greater than or equal to (>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (<) 50%, then the participants are considered as non-responders.
Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)
Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain.
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
The investigator evaluated each participant for CGIC questionnaire to assess change in participant's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events (AEs), and overall functional status of the participant using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement and higher score indicated worsening.

Full Information

First Posted
June 11, 2012
Last Updated
July 9, 2021
Sponsor
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01618695
Brief Title
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Official Title
A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2012 (Actual)
Primary Completion Date
September 15, 2014 (Actual)
Study Completion Date
May 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial-onset Seizures
Keywords
Partial-onset Seizures, partial seizures, seizure, epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
940 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perampanel
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Perampanel
Other Intervention Name(s)
E2007
Intervention Description
Core study: 4 milligram (mg) group- Week 0 Once daily 2 milligram per day (mg/day), Week 1 to Week 18 Once daily 4 mg/day; 8 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 to Week 18 Once daily 8 mg/day; 12 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 Once daily 8 mg/day, Week 4 Once daily 10 mg/day, Week 5 to Week 18 Once daily 12 mg/day. Extension study: 4 mg group- Week 19 to Week 22 Once daily 4 mg/day, Week 23 Once daily 6 mg/day, Week 24 Once daily 8 mg/day, Week 25 Once daily 10 mg/day, Week 26 to Week 75 or more Once daily 12 mg/day; 8 mg group- Week 19 to Week 22 Once daily 8 mg/day, Week 23 Once daily 10 mg/day, Week 24 to Week 75 or more Once daily 12 mg/day; 12 mg group- Week 19 to Week 75 or more Once daily 12 mg/day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Core study: Week 0 to Week 18 Once daily placebo. Extension study: Week 19 to Week 22 Once daily placebo, Week 23 Once daily perampanel 2 mg/day, Week 24 Once daily perampanel 4 mg/day, Week 25 Once daily perampanel 6 mg/day, Week 26 Once daily perampanel 8 mg/day, Week 27 Once daily perampanel 10 mg/day, Week 28 to Week 75 or more Once daily perampanel 12 mg/day.
Primary Outcome Measure Information:
Title
Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)
Description
Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness.
Time Frame
Baseline, Week 19
Secondary Outcome Measure Information:
Title
Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)
Description
Responder rate was percentage of participants with greater than or equal to (>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (<) 50%, then the participants are considered as non-responders.
Time Frame
Baseline, Week 19
Title
Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)
Description
Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain.
Time Frame
Baseline, Week 19
Title
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
Description
The investigator evaluated each participant for CGIC questionnaire to assess change in participant's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events (AEs), and overall functional status of the participant using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement and higher score indicated worsening.
Time Frame
Baseline, Week 19

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Male or female and greater than or equal to 12 years of age; Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures Participants with computed tomography (CT) or magnetic resonance imaging (MRI) diagnosis within the last 10 years (for adults) and 5 years (for adolescents) prior to visit 1 that ruled out progressive central nervous system (CNS) disorders, example, neurodegenerative disorders, brain tumors. For participants without existing CT or MRI results, CT or MRI was performed at or after Visit 1 but results evaluation was performed by Visit 2 Participants who had been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard antiepileptic drug (AED) for 2 years before enrollment During the 6-week Prerandomization Phase participants must have had greater than or equal to 5 partial seizures per 6-week Are currently being treated with stable doses and administrations of 1, 2, or a maximum of 3 approved AEDs. Only 1 inducer AED (defined as carbamazepine, phenytoin or oxcarbazepine only) out of the maximum of 3 AEDs is allowed Exclusion Criteria Presence of nonmotor simple partial seizures only; Presence of primary generalized epilepsies or seizures, such as absences and/or myoclonic epilepsies; Presence or previous history of Lennox-Gastaut syndrome; A history of status epilepticus within 1 year prior to screening Seizure clusters where individual seizures cannot be counted A history of psychogenic seizures within 5 years prior to screening
Facility Information:
Facility Name
Facility #1
City
Bedford Park
Country
Australia
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Facility #1
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Camperdown
Country
Australia
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Facility #1
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Clayton
Country
Australia
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Facility #1
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Fitzroy
Country
Australia
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Heidelberg
Country
Australia
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Facility #1
City
Melbourne
Country
Australia
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Facility #1
City
Randwick
Country
Australia
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Facility #1
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Beijing
State/Province
Beijing
Country
China
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Facility #1
City
Chongqing
State/Province
Chongqing
Country
China
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Facility #1
City
Xiamen
State/Province
Fujian
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China
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Guangzhou
State/Province
Guangdong
Country
China
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Facility #2
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Guangzhou
State/Province
Guangdong
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China
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Facility #1
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Harbin
State/Province
Heilongjiang
Country
China
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Facility #1
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Changchun
State/Province
Jilin
Country
China
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Facility #1
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Xi'an
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Shaanxi
Country
China
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City
Xi'an
State/Province
Shaanxi
Country
China
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City
Xi'an
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Shaanxi
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China
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Jinan
State/Province
Shandong
Country
China
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Facility #2
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Facility #1
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Facility #1
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Facility #2
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Facility #3
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Facility #1
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Facility #1
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Facility #2
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Facility #1
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Facility #1
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Facility #1
City
Wenzhou
State/Province
Zhejiang
Country
China
Facility Name
Eisai Trial Site #1
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Eisai Trial Site #2
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Eisai Trial Site #3
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Eisai Trial Site #1
City
Tōon
State/Province
Ehime
Country
Japan
Facility Name
Eisai Trial Site #1
City
Yoshida-gun
State/Province
Fukui
Country
Japan
Facility Name
Eisai Trial Site #1
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Eisai Trial Site #1
City
Koga
State/Province
Fukuoka
Country
Japan
Facility Name
Eisai Trial Site #1
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Eisai Trial Site #1
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Eisai Trial Site #2
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Eisai Trial Site #1
City
Itami
State/Province
Hyogo
Country
Japan
Facility Name
Eisai Trial Site #1
City
Tsuchiura
State/Province
Ibaraki
Country
Japan
Facility Name
Eisai Trial Site #1
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Eisai Trial Site #1
City
Zentsuji
State/Province
Kagawa
Country
Japan
Facility Name
Eisai Trial Site #1
City
Fujisawa
State/Province
Kanagawa
Country
Japan
Facility Name
Eisai Trial Site #1
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Eisai Trial Site #1
City
Goshi
State/Province
Kumamoto
Country
Japan
Facility Name
Eisai Trial Site #1
City
Tamana
State/Province
Kumamoto
Country
Japan
Facility Name
Eisai Trial Site #1
City
Iwanuma
State/Province
Miyagi
Country
Japan
Facility Name
Eisai Trial Site #1
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Eisai Trial Site #1
City
Miyakonojo
State/Province
Miyazaki
Country
Japan
Facility Name
Eisai Trial Site #1
City
Omura
State/Province
Nagasaki
Country
Japan
Facility Name
Eisai Trial Site #1
City
Beppu
State/Province
Oita
Country
Japan
Facility Name
Eisai Trial Site #1
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Eisai Trial Site #1
City
Izumi
State/Province
Osaka
Country
Japan
Facility Name
Eisai Trial Site #1
City
Osakasayama
State/Province
Osaka
Country
Japan
Facility Name
Eisai Trial Site #1
City
Sakai
State/Province
Osaka
Country
Japan
Facility Name
Eisai Trial Site #2
City
Sakai
State/Province
Osaka
Country
Japan
Facility Name
Eisai Trial Site #1
City
Takatsuki
State/Province
Osaka
Country
Japan
Facility Name
Eisai Trial Site #1
City
Asaka
State/Province
Saitama
Country
Japan
Facility Name
Eisai Trial Site #1
City
Higashimurayama
State/Province
Saitama
Country
Japan
Facility Name
Eisai Trial Site #1
City
Moriyama
State/Province
Shiga
Country
Japan
Facility Name
Eisai Trial Site #1
City
Matsue
State/Province
Shimane
Country
Japan
Facility Name
Eisai Trial Site #1
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Facility Name
Eisai Trial Site #1
City
Komatsushima
State/Province
Tokushima
Country
Japan
Facility Name
Eisai Trial Site #1
City
Kodaira
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trial Site #1
City
Kokubunji
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trial Site #1
City
Ube
State/Province
Yamaguchi
Country
Japan
Facility Name
Eisai Trial Site #1
City
Akita
Country
Japan
Facility Name
Eisai Trial Site #1
City
Aomori
Country
Japan
Facility Name
Eisai Trial Site #1
City
Fukui
Country
Japan
Facility Name
Eisai Trial Site #1
City
Fukuoka
Country
Japan
Facility Name
Eisai Trial Site #2
City
Fukuoka
Country
Japan
Facility Name
Eisai Trial Site #1
City
Gifu
Country
Japan
Facility Name
Eisai Trial Site #1
City
Hiroshima
Country
Japan
Facility Name
Eisai Trial Site #2
City
Hiroshima
Country
Japan
Facility Name
Eisai Trial Site #1
City
Kagoshima
Country
Japan
Facility Name
Eisai Trial Site #2
City
Kagoshima
Country
Japan
Facility Name
Eisai Trial Site #1
City
Kumamoto
Country
Japan
Facility Name
Eisai Trial Site #1
City
Kyoto
Country
Japan
Facility Name
Eisai Trial Site #1
City
Miyazaki
Country
Japan
Facility Name
Eisai Trial Site #1
City
Nara
Country
Japan
Facility Name
Eisai Trial Site #1
City
Niigata
Country
Japan
Facility Name
Eisai Trial Site #1
City
Okayama
Country
Japan
Facility Name
Eisai Trial Site #1
City
Saitama
Country
Japan
Facility Name
Eisai Trial Site #2
City
Saitama
Country
Japan
Facility Name
Eisai Trial Site #1
City
Shizuoka
Country
Japan
Facility Name
Eisai Trial Site #2
City
Shizuoka
Country
Japan
Facility Name
Eisai Trial Site #1
City
Toyama
Country
Japan
Facility Name
Eisai Trial Site #1
City
Yamagata
Country
Japan
Facility Name
Facility #1
City
Busan
Country
Korea, Republic of
Facility Name
Facility #2
City
Busan
Country
Korea, Republic of
Facility Name
Facility #1
City
Daegu
Country
Korea, Republic of
Facility Name
Facility #1
City
Daejeon
Country
Korea, Republic of
Facility Name
Facility #1
City
Gwangju
Country
Korea, Republic of
Facility Name
Facility #1
City
Incheon
Country
Korea, Republic of
Facility Name
Facility #1
City
Seoul
Country
Korea, Republic of
Facility Name
Facility #2
City
Seoul
Country
Korea, Republic of
Facility Name
Facility #3
City
Seoul
Country
Korea, Republic of
Facility Name
Facility #4
City
Seoul
Country
Korea, Republic of
Facility Name
Facility #5
City
Seoul
Country
Korea, Republic of
Facility Name
Facility #6
City
Seoul
Country
Korea, Republic of
Facility Name
Facility #7
City
Seoul
Country
Korea, Republic of
Facility Name
Facility #8
City
Seoul
Country
Korea, Republic of
Facility Name
Facility #1
City
Kuala Lumpur
Country
Malaysia
Facility Name
Facility #1
City
Perak
Country
Malaysia
Facility Name
Facility #1
City
Pulau Pinang
Country
Malaysia
Facility Name
Facility #1
City
Terengganu
Country
Malaysia
Facility Name
Facility #1
City
Taichung
Country
Taiwan
Facility Name
Facility #1
City
Tainan
Country
Taiwan
Facility Name
Facility #1
City
Taipei
Country
Taiwan
Facility Name
Facility #2
City
Taipei
Country
Taiwan
Facility Name
Facility #1
City
Taoyuan
Country
Taiwan
Facility Name
Facility #1
City
Rajathevee
Country
Thailand
Facility Name
Facility #1
City
Tha Muang
Country
Thailand
Facility Name
Facility #2
City
Tha Muang
Country
Thailand
Facility Name
Facility #3
City
Tha Muang
Country
Thailand
Facility Name
Facility #4
City
Tha Muang
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
29250772
Citation
Nishida T, Lee SK, Inoue Y, Saeki K, Ishikawa K, Kaneko S. Adjunctive perampanel in partial-onset seizures: Asia-Pacific, randomized phase III study. Acta Neurol Scand. 2018 Apr;137(4):392-399. doi: 10.1111/ane.12883. Epub 2017 Dec 17.
Results Reference
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A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

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