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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

This study is currently recruiting participants.
Verified December 2012 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01618695
First received: June 11, 2012
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Partial-onset Seizures
 Drug: E2007
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Perampanel
U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • The percent change in seizure frequency per 28 days in the Randomization Phase relative to the Prerandomization Phase [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 680
Study Start Date: May 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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 ≥ 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618695

Contacts
Contact: Customer Joy Department EJ _ML_CLNCL@hhc.eisai.co.jp

  Hide Study Locations
Locations
Japan
Recruiting
Nagoya, Aichi, Japan
Recruiting
Tohon, Ehime, Japan
Recruiting
Yoshida-gun, Fukui, Japan
Recruiting
Kitakyushu, Fukuoka, Japan
Recruiting
Kurume, Fukuoka, Japan
Recruiting
Tsuchiura, Ibaraki, Japan
Recruiting
Kanazawa, Ishikawa, Japan
Recruiting
Zentsuji, Kagawa, Japan
Recruiting
Fujisawa, Kanagawa, Japan
Recruiting
Kawasaki, Kanagawa, Japan
Recruiting
Goshi, Kumamoto, Japan
Recruiting
Iwanuma, Miyagi, Japan
Recruiting
Sendai, Miyagi, Japan
Recruiting
Miyakonojo, Miyazaki, Japan
Recruiting
Omura, Nagasaki, Japan
Recruiting
Beppu, Oita, Japan
Recruiting
Kurashiki, Okayama, Japan
Recruiting
Izumi, Osaka, Japan
Recruiting
Osakasayama, Osaka, Japan
Recruiting
Sakai, Osaka, Japan
Recruiting
Takatsuki, Osaka, Japan
Recruiting
Hamamatsu, Shizuoka, Japan
Recruiting
Komatsushima, Tokushima, Japan
Recruiting
Kodaira, Tokyo, Japan
Recruiting
Kokubunji, Tokyo, Japan
Recruiting
Akita, Japan
Recruiting
Fukui, Japan
Not yet recruiting
Fukuoka, Japan
Recruiting
Fukuoka, Japan
Recruiting
Gifu, Japan
Recruiting
Hiroshima, Japan
Recruiting
Kagoshima, Japan
Recruiting
Kyoto, Japan
Recruiting
Miyazaki, Japan
Recruiting
Nara, Japan
Recruiting
Niigata, Japan
Recruiting
Okayama, Japan
Recruiting
Saitama, Japan
Recruiting
Sapporo, Japan
Recruiting
Shizuoka, Japan
Recruiting
Toyama, Japan
Recruiting
Yamagata, Japan
Korea, Republic of
Recruiting
Busan, Korea, Republic of
Recruiting
Daegu, Korea, Republic of
Recruiting
Gwangju, Korea, Republic of
Recruiting
Incheon, Korea, Republic of
Recruiting
Seoul, Korea, Republic of
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.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01618695     History of Changes
Other Study ID Numbers: E2007-J000-335
Study First Received: June 11, 2012
Last Updated: December 5, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
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

ClinicalTrials.gov processed this record on June 18, 2013