A 14-month open-label extension phase of the double-blind, placebo-controlled, dose-escalation, parallel-group studies to evaluate the efficacy and safety of E2007 (perampanel) given as adjunctive therapy in subjects with refractory partial seizures
Phase 3
Completed
- Conditions
- epilepsyfalling disease10039911
- Registration Number
- NL-OMON32105
- Lead Sponsor
- Eisai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
- Have completed visit 8 of study E2007-G000-304, E2007-G000-305 or E2007-G000-306 and shown compliance with the inclusion and exclusion criteria for that study (exluding criteria that are related to seizure occurences)
- Continue to be treated with a stable dose of 1 or maximum of 3 approved AEDs
Exclusion Criteria
- Those who, for any reason, discontinued early from the preceding double-blind study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>For subjects who were assigned to the perampanel treatment arms during the<br /><br>preceding double-blind studies, the following variables will be analyzed over<br /><br>the Double-blind Phase plus the Open-label Treatment Phase (Conversion Period +<br /><br>Maintenance Period) relative to Pre-randomization Phase of the double-blind<br /><br>study. For subjects who were assigned to the placebo arms during the<br /><br>double-blind studies, the following variables will only be analyzed over the<br /><br>Open-label Treatment Phase (Conversion Period + Maintenance Period) relative to<br /><br>Pre-randomization Phase of the double-blind study:<br /><br>1. Percent change in seizure frequency per 28 days<br /><br>2. Proportion of patient who experience a 50% or greater reduction in seizure<br /><br>frequency per 28 days (responder rate analysis)<br /><br>3. Percent change in seizure frequency per 28 days per seizure type<br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>The safety will be examined based on nature, frequency, and severity of adverse<br /><br>events, chemistry and hematology laboratory test results, vital signs, and<br /><br>12-lead ECG abnormalities over the perampanel treatment period </p><br>