CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 133 enrolled
Drug / intervention
Perampanel +1 moredrug
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.

Search/NCT01161524
NCT01161524Phase 2Completed

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics When Administered as an Adjunctive Therapy in Adolescents (12 to Less Than 18 Years of Age) With Inadequately Controlled Partial-onset Seizures

Eisai Inc.·interventional·Posted Jul 13, 2010·Updated May 15, 2019

In Brief

A Phase 2 clinical trial evaluating Perampanel and Placebo for Epilepsy. Completed, enrolled 133 participants across 37 sites in 11 countries.

Detailed Summary

This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustralia, Belgium, Czechia, Hungary, India, Latvia, Poland, South Korea, Spain, Thailand, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2010
Enrollment StartSep 1, 2010
Primary CompletionJun 1, 2013
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.0 years ago

Interventions

Perampaneldrug

2 mg titrated up to 8-12 mg maximum; taken once daily.

Placebodrug

Matching Placebo taken once daily.