NCT00699582

To Evaluate The Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 389 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.

Conditions

• Refractory Partial Seizures

Interventions

Type	Name	Description
DRUG	E2007 (perampanel)	8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.
DRUG	E2007 (perampanel)	12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.
DRUG	Placebo	Placebo in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study.

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2008-06-18
• Last updated: 2014-07-11
• Results posted: 2012-11-22

Locations

92 sites across 14 countries: United States, Austria, Belgium, Finland, France, Germany, India, Israel, Italy, Netherlands, Russia, South Africa, Sweden, United Kingdom