At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,218 enrolled
Drug / intervention
perampaneldrug
Likely dose
perampanel 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating perampanel for Epilepsy. Completed, enrolled 1,218 participants across 239 sites in 39 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesArgentina, 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, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartOct 2008
Primary CompletionSep 2014
TodayJul 2026
First PostedAug 14, 2008
Enrollment StartOct 1, 2008
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 17.9 years ago
Interventions
perampaneldrug
Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years