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

PHASE3CompletedINTERVENTIONAL
Enrollment

940

Participants

Timeline

Start Date

May 15, 2012

Primary Completion Date

September 15, 2014

Study Completion Date

May 28, 2020

Conditions
Partial-onset Seizures
Interventions
DRUG

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."

DRUG

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."

Trial Locations (117)

Unknown

Facility #1, Bedford Park

Facility #1, Camperdown

Facility #1, Clayton

Facility #1, Fitzroy

Facility #1, Heidelberg

Facility #1, Melbourne

Facility #1, Randwick

Facility #1, Beijing

Facility #1, Chongqing

Facility #1, Xiamen

Facility #1, Guangzhou

Facility #2, Guangzhou

Facility #1, Harbin

Facility #1, Changchun

Facility #1, Xi'an

Facility #2, Xi'an

Facility #3, Xi'an

Facility #1, Taiyuan

Facility #1, Jinan

Facility #2, Jinan

Facility #1, Qingdao

Facility #1, Shanghai

Facility #2, Shanghai

Facility #3, Shanghai

Facility #1, Chengdu

Facility #2, Chengdu

Facility #1, Tianjin

Facility #1, Kunming

Facility #1, Wenzhou

Eisai Trial Site #1, Nagoya

Eisai Trial Site #2, Nagoya

Eisai Trial Site #3, Nagoya

Eisai Trial Site #1, Tōon

Eisai Trial Site #1, Yoshida-gun

Eisai Trial Site #1, Kitakyushu

Eisai Trial Site #1, Koga

Eisai Trial Site #1, Kurume

Eisai Trial Site #1, Sapporo

Eisai Trial Site #2, Sapporo

Eisai Trial Site #1, Itami

Eisai Trial Site #1, Tsuchiura

Eisai Trial Site #1, Kanazawa

Eisai Trial Site #1, Zentsujichó

Eisai Trial Site #1, Fujisawa

Eisai Trial Site #1, Kawasaki

Eisai Trial Site #1, Gōshi

Eisai Trial Site #1, Tamana

Eisai Trial Site #1, Iwanuma

Eisai Trial Site #1, Sendai

Eisai Trial Site #1, Miyakonojō

Eisai Trial Site #1, Ōmura

Eisai Trial Site #1, Beppu

Eisai Trial Site #1, Kurashiki

Eisai Trial Site #1, Izumi

Eisai Trial Site #1, Sakai

Eisai Trial Site #2, Sakai

Eisai Trial Site #1, Sayama

Eisai Trial Site #1, Takatsuki

Eisai Trial Site #1, Asaka

Eisai Trial Site #1, Higashimurayama

Eisai Trial Site #1, Moriyama

Eisai Trial Site #1, Matsue

Eisai Trial Site #1, Hamamatsu

Eisai Trial Site #1, Komatsushimachō

Eisai Trial Site #1, Kodaira

Eisai Trial Site #1, Kokubunji

Eisai Trial Site #1, Ube

Eisai Trial Site #1, Akita

Eisai Trial Site #1, Aomori

Eisai Trial Site #1, Fukui

Eisai Trial Site #1, Fukuoka

Eisai Trial Site #2, Fukuoka

Eisai Trial Site #1, Gifu

Eisai Trial Site #1, Hiroshima

Eisai Trial Site #2, Hiroshima

Eisai Trial Site #1, Kagoshima

Eisai Trial Site #2, Kagoshima

Eisai Trial Site #1, Kumamoto

Eisai Trial Site #1, Kyoto

Eisai Trial Site #1, Miyazaki

Eisai Trial Site #1, Nara

Eisai Trial Site #1, Niigata

Eisai Trial Site #1, Okayama

Eisai Trial Site #1, Saitama

Eisai Trial Site #2, Saitama

Eisai Trial Site #1, Shizuoka

Eisai Trial Site #2, Shizuoka

Eisai Trial Site #1, Toyama

Eisai Trial Site #1, Yamagata

Facility #1, Kuala Lumpur

Facility #1, Perak

Facility #1, Pulau Pinang

Facility #1, Terengganu

Facility #1, Busan

Facility #2, Busan

Facility #1, Daegu

Facility #1, Daejeon

Facility #1, Gwangju

Facility #1, Incheon

Facility #1, Seoul

Facility #2, Seoul

Facility #3, Seoul

Facility #4, Seoul

Facility #5, Seoul

Facility #6, Seoul

Facility #7, Seoul

Facility #8, Seoul

Facility #1, Taichung

Facility #1, Tainan City

Facility #1, Taipei

Facility #2, Taipei

Facility #1, Taoyuan District

Facility #1, Rajathevee

Facility #1, Tha Muang

Facility #2, Tha Muang

Facility #3, Tha Muang

Facility #4, Tha Muang

All Listed Sponsors
lead

Eisai Co., Ltd.

INDUSTRY

NCT01618695 - 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 | Biotech Hunter | Biotech Hunter