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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01618695
First received: June 11, 2012
Last updated: July 10, 2014
Last verified: July 2014
  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:


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: December 2014
Estimated Primary Completion Date: November 2014 (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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618695

  Show 89 Study Locations
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: July 10, 2014
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
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014