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 February 2014 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: February 13, 2014
Last verified: February 2014

June 11, 2012
February 13, 2014
May 2012
September 2015   (final data collection date for primary outcome measure)
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.
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 effiacy 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.
Complete list of historical versions of study NCT01618695 on ClinicalTrials.gov Archive Site
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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
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

The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Partial-onset Seizures
  • 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

  • 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

  • Experimental: Perampanel
    Intervention: Drug: E2007
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
680
September 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact: Customer Joy Department EJ _ML_CLNCL@hhc.eisai.co.jp
Australia,   China,   Japan,   Korea, Republic of,   Malaysia,   Taiwan,   Thailand
 
NCT01618695
E2007-J000-335
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Kazunori Saeki Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Product Creation Systems, Eisai Co., Ltd.
Eisai Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP