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
NCT ID: NCT01618695
Last Updated: 2021-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
940 participants
INTERVENTIONAL
2012-05-15
2020-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Perampanel
Perampanel
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.
Placebo
Placebo
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.
Interventions
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Perampanel
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.
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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 City, , 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
Countries
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References
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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.
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.
Other Identifiers
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E2007-J000-335
Identifier Type: -
Identifier Source: org_study_id
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