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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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ClinicalTrials.gov Identifier: NCT01618695
Recruitment Status : Active, not recruiting
First Posted : June 13, 2012
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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

Condition or disease Intervention/treatment Phase
Partial-onset Seizures Drug: E2007 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 17, 2012
Actual Primary Completion Date : September 15, 2014
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Perampanel

Arm Intervention/treatment
Experimental: Perampanel Drug: E2007

Core study:4 mg group:

Week 0 Once daily; 2 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 perampanel 4 mg/day, Week 23 Once daily perampanel 6 mg/day, Week 24 Once daily perampanel 8 mg/day, Week 25 Once daily perampanel 10 mg/day,

Week 26 to Week 75 or more Once daily perampanel 12 mg/day:

8 mg group: Week 19 to Week 22 Once daily perampanel 8 mg/day, Week 23 Once daily perampanel 10 mg/day,

Week 24 to Week 75 or more Once daily perampanel 12 mg/day:

12 mg group: Week 19 to Week 75 or more Once daily perampanel 12 mg/day


Placebo Comparator: Placebo Drug: Placebo

Core study:

Week 0 to Week 18 Once daily placebo, Week 19 to Week 22 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 Measures :
  1. The percent change in seizure frequency per 28 days in the Randomization Phase relative to the Prerandomization Phase [ Time Frame: 19 weeks ]
    The primary efficacy endpoint will be the percent change in seizure frequency per 28 days in the Randomization Phase relative to the Prerandomization Phase in the ITT ANalysis Set.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Subjects with computed tomography (CT) or magnetic resonance imaging (MRI) diagnosis
  4. Subjects who had been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard AED for 2 years before enrollment
  5. During the 6-week Prerandomization Phase subjects must have had greater than or equal to 5 partial seizures per 6-week
  6. Are on a stable dose and administration of the same concomitant AED(s) for 1 month prior to Visit 1

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 before enrollment in Prerandomization Phase
  5. Seizure clusters where individual seizures cannot be counted
  6. A history of psychogenic seizures within 5 years before enrollment in Prerandomization Phase

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618695


  Hide Study Locations
Locations
Australia
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
China, Beijing
Facility #1
Beijing, Beijing, China
China, Chongqing
Facility #1
Chongqing, Chongqing, China
China, Fujian
Facility #1
Guangzhou, Fujian, China
Facility #1
Xiamen, Fujian, China
China, Guangdong
Facility #2
Guangzhou, Guangdong, China
China, Heilongjiang
Facility #1
Harbin, Heilongjiang, China
China, Jilin
Facility #1
Changchun, Jilin, China
China, Shaanxi
Facility #1
Xi'an, Shaanxi, China
Facility #2
Xi'an, Shaanxi, China
Facility #3
Xi'an, Shaanxi, China
China, Shandong
Facility #1
Jinan, Shandong, China
Facility #2
Jinan, Shandong, China
Facility #1
Qingdao, Shandong, China
China, Shanghai
Facility #1
Shanghai, Shanghai, China
Facility #2
Shanghai, Shanghai, China
Facility #3
Shanghai, Shanghai, China
China, Shanxi
Facility #1
Taiyuan, Shanxi, China
China, Sichuan
Facility #1
Chengdu, Sichuan, China
Facility #2
Chengdu, Sichuan, China
China, Tianjin
Facility #1
Tianjin, Tianjin, China
China, Yunnan
Facility #1
Kunming, Yunnan, China
China, Zhejiang
Facility #1
Wenzhou, Zhejiang, China
Japan
Eisai Trial Site #1
Nagoya, Aichi, Japan
Eisai Trial Site #2
Nagoya, Aichi, Japan
Eisai Trial Site #3
Nagoya, Aichi, 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, Hyogo, Japan
Eisai Trial Site #1
Tsuchiura, Ibaraki, Japan
Eisai Trial Site #1
Kanazawa, Ishikawa, Japan
Eisai Trial Site #1
Zentsuji, Kagawa, Japan
Eisai Trial Site #1
Fujisawa, Kanagawa, Japan
Eisai Trial Site #1
Kawasaki, Kanagawa, Japan
Eisai Trial Site #1
Goshi, 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
Miyakonojo, Miyazaki, Japan
Eisai Trial Site #1
Omura, Nagasaki, Japan
Eisai Trial Site #1
Beppu, Oita, Japan
Eisai Trial Site #1
Kurashiki, Okayama, Japan
Eisai Trial Site #1
Izumi, Osaka, Japan
Eisai Trial Site #1
Osakasayama, Osaka, Japan
Eisai Trial Site #1
Sakai, Osaka, Japan
Eisai Trial Site #2
Sakai, 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
Komatsushima, 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
Korea, Republic of
Facility #1
Busan, Korea, Republic of
Facility #2
Busan, Korea, Republic of
Facility #1
Daegu, Korea, Republic of
Facility #1
Daejeon, Korea, Republic of
Facility #1
Gwangju, Korea, Republic of
Facility #1
Incheon, Korea, Republic of
Facility #1
Seoul, Korea, Republic of
Facility #2
Seoul, Korea, Republic of
Facility #3
Seoul, Korea, Republic of
Facility #4
Seoul, Korea, Republic of
Facility #5
Seoul, Korea, Republic of
Facility #6
Seoul, Korea, Republic of
Facility #7
Seoul, Korea, Republic of
Facility #8
Seoul, Korea, Republic of
Malaysia
Facility #1
Kuala Lumpur, Malaysia
Facility #1
Perak, Malaysia
Facility #1
Pulau Pinang, Malaysia
Facility #1
Terengganu, Malaysia
Taiwan
Facility #1
Taichung, Taiwan
Facility #1
Tainan, Taiwan
Facility #1
Taipei, Taiwan
Facility #2
Taipei, Taiwan
Facility #1
Taoyuan, Taiwan
Thailand
Facility #1
Rajathevee, Thailand
Facility #1
Tha Muang, Thailand
Facility #2
Tha Muang, Thailand
Facility #3
Tha Muang, Thailand
Facility #4
Tha Muang, Thailand
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Kazunori Saeki Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Product Creation Systems, Eisai Co., Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01618695     History of Changes
Other Study ID Numbers: E2007-J000-335
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Partial-onset Seizures
partial seizures
seizure
epilepsy

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms