At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 163 enrolled
Drug / intervention
Perampanel +1 moredrug
Likely dose
Not stated in 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.
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
In Brief
A Phase 3 clinical trial evaluating Perampanel and Placebo comparator for Seizure Disorder Generalized Tonic Clonic. Completed, enrolled 163 participants.
Detailed Summary
This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and adults maintained on one to two stable antiepileptic drugs (AED).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartSep 2011
Primary CompletionMay 2014
Study CompletionNov 2015
TodayJul 2026
First PostedJul 13, 2011
Enrollment StartSep 1, 2011
Primary CompletionMay 1, 2014
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.0 years ago
Interventions
Perampaneldrug
Placebo comparatordrug