Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial-onset Seizures
Keywords: Partial-onset Seizures
partial seizures
seizure
epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-13
Enrollment: 940
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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. 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

Primary outcomes:
measure: Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)
timeFrame: Baseline, Week 19
Secondary outcomes:
measure: Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 19
measure: 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)
timeFrame: Baseline, Week 19
measure: Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
timeFrame: Baseline, Week 19
Other outcomes:
Locations:
city: Bedford Park
country: Australia
facility: Facility #1
city: Camperdown
country: Australia
facility: Facility #1
city: Clayton
country: Australia
facility: Facility #1
city: Fitzroy
country: Australia
facility: Facility #1
city: Heidelberg
country: Australia
facility: Facility #1
city: Melbourne
country: Australia
facility: Facility #1
city: Randwick
country: Australia
facility: Facility #1
city: Beijing
country: China
facility: Facility #1
state: Beijing
city: Chongqing
country: China
facility: Facility #1
state: Chongqing
city: Xiamen
country: China
facility: Facility #1
state: Fujian
city: Guangzhou
country: China
facility: Facility #1
state: Guangdong
city: Guangzhou
country: China
facility: Facility #2
state: Guangdong
city: Harbin
country: China
facility: Facility #1
state: Heilongjiang
city: Changchun
country: China
facility: Facility #1
state: Jilin
city: Xi'an
country: China
facility: Facility #1
state: Shaanxi
city: Xi'an
country: China
facility: Facility #2
state: Shaanxi
city: Xi'an
country: China
facility: Facility #3
state: Shaanxi
city: Jinan
country: China
facility: Facility #1
state: Shandong
city: Jinan
country: China
facility: Facility #2
state: Shandong
city: Qingdao
country: China
facility: Facility #1
state: Shandong
city: Shanghai
country: China
facility: Facility #1
state: Shanghai
city: Shanghai
country: China
facility: Facility #2
state: Shanghai
city: Shanghai
country: China
facility: Facility #3
state: Shanghai
city: Taiyuan
country: China
facility: Facility #1
state: Shanxi
city: Chengdu
country: China
facility: Facility #1
state: Sichuan
city: Chengdu
country: China
facility: Facility #2
state: Sichuan
city: Tianjin
country: China
facility: Facility #1
state: Tianjin
city: Kunming
country: China
facility: Facility #1
state: Yunnan
city: Wenzhou
country: China
facility: Facility #1
state: Zhejiang
city: Nagoya
country: Japan
facility: Eisai Trial Site #1
state: Aichi
city: Nagoya
country: Japan
facility: Eisai Trial Site #2
state: Aichi
city: Nagoya
country: Japan
facility: Eisai Trial Site #3
state: Aichi
city: Tōon
country: Japan
facility: Eisai Trial Site #1
state: Ehime
city: Yoshida-gun
country: Japan
facility: Eisai Trial Site #1
state: Fukui
city: Kitakyushu
country: Japan
facility: Eisai Trial Site #1
state: Fukuoka
city: Koga
country: Japan
facility: Eisai Trial Site #1
state: Fukuoka
city: Kurume
country: Japan
facility: Eisai Trial Site #1
state: Fukuoka
city: Sapporo
country: Japan
facility: Eisai Trial Site #1
state: Hokkaido
city: Sapporo
country: Japan
facility: Eisai Trial Site #2
state: Hokkaido
city: Itami
country: Japan
facility: Eisai Trial Site #1
state: Hyogo
city: Tsuchiura
country: Japan
facility: Eisai Trial Site #1
state: Ibaraki
city: Kanazawa
country: Japan
facility: Eisai Trial Site #1
state: Ishikawa
city: Zentsuji
country: Japan
facility: Eisai Trial Site #1
state: Kagawa
city: Fujisawa
country: Japan
facility: Eisai Trial Site #1
state: Kanagawa
city: Kawasaki
country: Japan
facility: Eisai Trial Site #1
state: Kanagawa
city: Goshi
country: Japan
facility: Eisai Trial Site #1
state: Kumamoto
city: Tamana
country: Japan
facility: Eisai Trial Site #1
state: Kumamoto
city: Iwanuma
country: Japan
facility: Eisai Trial Site #1
state: Miyagi
city: Sendai
country: Japan
facility: Eisai Trial Site #1
state: Miyagi
city: Miyakonojo
country: Japan
facility: Eisai Trial Site #1
state: Miyazaki
city: Omura
country: Japan
facility: Eisai Trial Site #1
state: Nagasaki
city: Beppu
country: Japan
facility: Eisai Trial Site #1
state: Oita
city: Kurashiki
country: Japan
facility: Eisai Trial Site #1
state: Okayama
city: Izumi
country: Japan
facility: Eisai Trial Site #1
state: Osaka
city: Osakasayama
country: Japan
facility: Eisai Trial Site #1
state: Osaka
city: Sakai
country: Japan
facility: Eisai Trial Site #1
state: Osaka
city: Sakai
country: Japan
facility: Eisai Trial Site #2
state: Osaka
city: Takatsuki
country: Japan
facility: Eisai Trial Site #1
state: Osaka
city: Asaka
country: Japan
facility: Eisai Trial Site #1
state: Saitama
city: Higashimurayama
country: Japan
facility: Eisai Trial Site #1
state: Saitama
city: Moriyama
country: Japan
facility: Eisai Trial Site #1
state: Shiga
city: Matsue
country: Japan
facility: Eisai Trial Site #1
state: Shimane
city: Hamamatsu
country: Japan
facility: Eisai Trial Site #1
state: Shizuoka
city: Komatsushima
country: Japan
facility: Eisai Trial Site #1
state: Tokushima
city: Kodaira
country: Japan
facility: Eisai Trial Site #1
state: Tokyo
city: Kokubunji
country: Japan
facility: Eisai Trial Site #1
state: Tokyo
city: Ube
country: Japan
facility: Eisai Trial Site #1
state: Yamaguchi
city: Akita
country: Japan
facility: Eisai Trial Site #1
city: Aomori
country: Japan
facility: Eisai Trial Site #1
city: Fukui
country: Japan
facility: Eisai Trial Site #1
city: Fukuoka
country: Japan
facility: Eisai Trial Site #1
city: Fukuoka
country: Japan
facility: Eisai Trial Site #2
city: Gifu
country: Japan
facility: Eisai Trial Site #1
city: Hiroshima
country: Japan
facility: Eisai Trial Site #1
city: Hiroshima
country: Japan
facility: Eisai Trial Site #2
city: Kagoshima
country: Japan
facility: Eisai Trial Site #1
city: Kagoshima
country: Japan
facility: Eisai Trial Site #2
city: Kumamoto
country: Japan
facility: Eisai Trial Site #1
city: Kyoto
country: Japan
facility: Eisai Trial Site #1
city: Miyazaki
country: Japan
facility: Eisai Trial Site #1
city: Nara
country: Japan
facility: Eisai Trial Site #1
city: Niigata
country: Japan
facility: Eisai Trial Site #1
city: Okayama
country: Japan
facility: Eisai Trial Site #1
city: Saitama
country: Japan
facility: Eisai Trial Site #1
city: Saitama
country: Japan
facility: Eisai Trial Site #2
city: Shizuoka
country: Japan
facility: Eisai Trial Site #1
city: Shizuoka
country: Japan
facility: Eisai Trial Site #2
city: Toyama
country: Japan
facility: Eisai Trial Site #1
city: Yamagata
country: Japan
facility: Eisai Trial Site #1
city: Busan
country: Korea, Republic of
facility: Facility #1
city: Busan
country: Korea, Republic of
facility: Facility #2
city: Daegu
country: Korea, Republic of
facility: Facility #1
city: Daejeon
country: Korea, Republic of
facility: Facility #1
city: Gwangju
country: Korea, Republic of
facility: Facility #1
city: Incheon
country: Korea, Republic of
facility: Facility #1
city: Seoul
country: Korea, Republic of
facility: Facility #1
city: Seoul
country: Korea, Republic of
facility: Facility #2
city: Seoul
country: Korea, Republic of
facility: Facility #3
city: Seoul
country: Korea, Republic of
facility: Facility #4
city: Seoul
country: Korea, Republic of
facility: Facility #5
city: Seoul
country: Korea, Republic of
facility: Facility #6
city: Seoul
country: Korea, Republic of
facility: Facility #7
city: Seoul
country: Korea, Republic of
facility: Facility #8
city: Kuala Lumpur
country: Malaysia
facility: Facility #1
city: Perak
country: Malaysia
facility: Facility #1
city: Pulau Pinang
country: Malaysia
facility: Facility #1
city: Terengganu
country: Malaysia
facility: Facility #1
city: Taichung
country: Taiwan
facility: Facility #1
city: Tainan
country: Taiwan
facility: Facility #1
city: Taipei
country: Taiwan
facility: Facility #1
city: Taipei
country: Taiwan
facility: Facility #2
city: Taoyuan
country: Taiwan
facility: Facility #1
city: Rajathevee
country: Thailand
facility: Facility #1
city: Tha Muang
country: Thailand
facility: Facility #1
city: Tha Muang
country: Thailand
facility: Facility #2
city: Tha Muang
country: Thailand
facility: Facility #3
city: Tha Muang
country: Thailand
facility: Facility #4
Study officials:
References:
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.