A double-blind, placebo-controlled, dose-escalation, parallel-group study to evaluate the efficacy and safety of E2007 (perampanel) given as adjunctive therapy in subjects with refractory partial seizures.
- Conditions
- epilepsy10039911
- Registration Number
- NL-OMON35288
- Lead Sponsor
- Eisai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
*Be considered reliable and willing to be available for the study period and is able to record seizures and report AEs them self or have a caregiver who can record seizures and report AEs for them
*Male or female and greater than or equal to 18 years of age
*Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures according to the International League Against Epilepsy*s Classification of Epileptic Seizures (1981).
*Have uncontrolled partial seizures despite having been treated with at least 2 different AEDs within approximately the last 2 years;
*Are on a stable dose of the same concomitant AED(s) for 1 month (or no less than 21 days) prior to Visit 1;
* Presence of nonmotor simple partial seizures only;
* Presence of primary generalized epilepsies or seizures, such as absences and or myoclonic epilepsies;
* Presence or previous history of Lennox-Gastaut syndrome;
* A history of status epilepticus within approximately 12 months prior to Visit 1;
* Seizure clusters where individual seizures cannot be counted;
* A history of psychogenic seizures;
* Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject*s safety or the study conduct;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method