NCT00735397

Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

An 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,218 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.

Detailed description

This was an open-label extension (OLE) study for subjects who completed one of the following double-blind, placebo-controlled, Phase 3 studies: E2007-G000-304 (NCT00699972), E2007-G000-305 (NCT00699582), and E2007-G000-306 (NCT00700310). This OLE study consisted of 2 phases: an Open-label Treatment Phase (comprised of a 16-week blinded Conversion Period and a 256-week Maintenance Period) and a Follow-up Phase (4 weeks). During the Conversion Period, subjects and investigators remained blinded to the treatment received in the previous DB study. To achieve this, all subjects continued to take 6 tablets of study medication (2 mg perampanel or matching placebo) or fewer as they were instructed during the core Double-Blind (DB) study. During the open-label Maintenance Period, subjects were treated with the perampanel dose that provided the best combination of individual efficacy and tolerability.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	perampanel	Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years

Timeline

• Start date: 2008-10-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2008-08-14
• Last updated: 2016-03-14
• Results posted: 2016-01-26

Locations

239 sites across 39 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Czechia, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Russia, Serbia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom