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
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
1 other identifier
interventional
940
7 countries
117
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2012
Longer than P75 for phase_3
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2012
CompletedFirst Submitted
Initial submission to the registry
June 11, 2012
CompletedFirst Posted
Study publicly available on registry
June 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2020
CompletedResults Posted
Study results publicly available
June 5, 2020
CompletedJuly 29, 2021
July 1, 2021
2.3 years
June 11, 2012
May 20, 2020
July 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Week 19
Secondary Outcomes (3)
Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)
Baseline, Week 19
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)
Baseline, Week 19
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
Baseline, Week 19
Study Arms (2)
Perampanel
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (117)
Facility #1
Bedford Park, Australia
Facility #1
Camperdown, Australia
Facility #1
Clayton, Australia
Facility #1
Fitzroy, Australia
Facility #1
Heidelberg, Australia
Facility #1
Melbourne, Australia
Facility #1
Randwick, Australia
Facility #1
Beijing, Beijing Municipality, China
Facility #1
Chongqing, Chongqing Municipality, China
Facility #1
Xiamen, Fujian, China
Facility #1
Guangzhou, Guangdong, China
Facility #2
Guangzhou, Guangdong, China
Facility #1
Harbin, Heilongjiang, China
Facility #1
Changchun, Jilin, China
Facility #1
Xi'an, Shaanxi, China
Facility #2
Xi'an, Shaanxi, China
Facility #3
Xi'an, Shaanxi, China
Facility #1
Taiyuan, Shan'xi, China
Facility #1
Jinan, Shandong, China
Facility #2
Jinan, Shandong, China
Facility #1
Qingdao, Shandong, China
Facility #1
Shanghai, Shanghai Municipality, China
Facility #2
Shanghai, Shanghai Municipality, China
Facility #3
Shanghai, Shanghai Municipality, China
Facility #1
Chengdu, Sichuan, China
Facility #2
Chengdu, Sichuan, China
Facility #1
Tianjin, Tianjin Municipality, China
Facility #1
Kunming, Yunnan, China
Facility #1
Wenzhou, Zhejiang, China
Eisai Trial Site #1
Nagoya, Aichi-ken, Japan
Eisai Trial Site #2
Nagoya, Aichi-ken, Japan
Eisai Trial Site #3
Nagoya, Aichi-ken, Japan
Eisai Trial Site #1
Tōon, Ehime, Japan
Eisai Trial Site #1
Yoshida-gun, Fukui, Japan
Eisai Trial Site #1
Kitakyushu, Fukuoka, Japan
Eisai Trial Site #1
Koga, Fukuoka, Japan
Eisai Trial Site #1
Kurume, Fukuoka, Japan
Eisai Trial Site #1
Sapporo, Hokkaido, Japan
Eisai Trial Site #2
Sapporo, Hokkaido, Japan
Eisai Trial Site #1
Itami, Hyōgo, Japan
Eisai Trial Site #1
Tsuchiura, Ibaraki, Japan
Eisai Trial Site #1
Kanazawa, Ishikawa-ken, Japan
Eisai Trial Site #1
Zentsujichó, Kagawa-ken, Japan
Eisai Trial Site #1
Fujisawa, Kanagawa, Japan
Eisai Trial Site #1
Kawasaki, Kanagawa, Japan
Eisai Trial Site #1
Gōshi, Kumamoto, Japan
Eisai Trial Site #1
Tamana, Kumamoto, Japan
Eisai Trial Site #1
Iwanuma, Miyagi, Japan
Eisai Trial Site #1
Sendai, Miyagi, Japan
Eisai Trial Site #1
Miyakonojō, Miyazaki, Japan
Eisai Trial Site #1
Ōmura, Nagasaki, Japan
Eisai Trial Site #1
Beppu, Oita Prefecture, Japan
Eisai Trial Site #1
Kurashiki, Okayama-ken, Japan
Eisai Trial Site #1
Izumi, Osaka, Japan
Eisai Trial Site #1
Sakai, Osaka, Japan
Eisai Trial Site #2
Sakai, Osaka, Japan
Eisai Trial Site #1
Sayama, Osaka, Japan
Eisai Trial Site #1
Takatsuki, Osaka, Japan
Eisai Trial Site #1
Asaka, Saitama, Japan
Eisai Trial Site #1
Higashimurayama, Saitama, Japan
Eisai Trial Site #1
Moriyama, Shiga, Japan
Eisai Trial Site #1
Matsue, Shimane, Japan
Eisai Trial Site #1
Hamamatsu, Shizuoka, Japan
Eisai Trial Site #1
Komatsushimachō, Tokushima, Japan
Eisai Trial Site #1
Kodaira, Tokyo, Japan
Eisai Trial Site #1
Kokubunji, Tokyo, Japan
Eisai Trial Site #1
Ube, Yamaguchi, Japan
Eisai Trial Site #1
Akita, Japan
Eisai Trial Site #1
Aomori, Japan
Eisai Trial Site #1
Fukui, Japan
Eisai Trial Site #1
Fukuoka, Japan
Eisai Trial Site #2
Fukuoka, Japan
Eisai Trial Site #1
Gifu, Japan
Eisai Trial Site #1
Hiroshima, Japan
Eisai Trial Site #2
Hiroshima, Japan
Eisai Trial Site #1
Kagoshima, Japan
Eisai Trial Site #2
Kagoshima, Japan
Eisai Trial Site #1
Kumamoto, Japan
Eisai Trial Site #1
Kyoto, Japan
Eisai Trial Site #1
Miyazaki, Japan
Eisai Trial Site #1
Nara, Japan
Eisai Trial Site #1
Niigata, Japan
Eisai Trial Site #1
Okayama, Japan
Eisai Trial Site #1
Saitama, Japan
Eisai Trial Site #2
Saitama, Japan
Eisai Trial Site #1
Shizuoka, Japan
Eisai Trial Site #2
Shizuoka, Japan
Eisai Trial Site #1
Toyama, Japan
Eisai Trial Site #1
Yamagata, Japan
Facility #1
Kuala Lumpur, Malaysia
Facility #1
Perak, Malaysia
Facility #1
Pulau Pinang, Malaysia
Facility #1
Terengganu, Malaysia
Facility #1
Busan, South Korea
Facility #2
Busan, South Korea
Facility #1
Daegu, South Korea
Facility #1
Daejeon, South Korea
Facility #1
Gwangju, South Korea
Facility #1
Incheon, South Korea
Facility #1
Seoul, South Korea
Facility #2
Seoul, South Korea
Facility #3
Seoul, South Korea
Facility #4
Seoul, South Korea
Facility #5
Seoul, South Korea
Facility #6
Seoul, South Korea
Facility #7
Seoul, South Korea
Facility #8
Seoul, South Korea
Facility #1
Taichung, Taiwan
Facility #1
Tainan, Taiwan
Facility #1
Taipei, Taiwan
Facility #2
Taipei, Taiwan
Facility #1
Taoyuan District, Taiwan
Facility #1
Rajathevee, Thailand
Facility #1
Tha Muang, Thailand
Facility #2
Tha Muang, Thailand
Facility #3
Tha Muang, Thailand
Facility #4
Tha Muang, Thailand
Related Publications (2)
Bresnahan R, Hill RA, Wang J. Perampanel add-on for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD010961. doi: 10.1002/14651858.CD010961.pub2.
PMID: 37059702DERIVEDNishida 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.
PMID: 29250772DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Inquiry Service.
- Organization
- Eisai Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2012
First Posted
June 13, 2012
Study Start
May 15, 2012
Primary Completion
September 15, 2014
Study Completion
May 28, 2020
Last Updated
July 29, 2021
Results First Posted
June 5, 2020
Record last verified: 2021-07