CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 390 enrolled
Drug / intervention
E2007 (perampanel) +2 moredrug
Likely dose
E2007 (perampanel) 8 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/NCT00699972
NCT00699972Phase 3Completed
CompareCT.gov

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

Eisai Inc.·interventional·Posted Jun 18, 2008·Updated Jan 10, 2020

In Brief

A Phase 3 clinical trial evaluating E2007 (perampanel) and Placebo for Refractory Partial Seizures. Completed, enrolled 390 participants across 97 sites in 6 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRefractory Partial Seizures
CountriesArgentina, Brazil, Canada, Chile, Mexico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 18, 2008
Enrollment StartApr 30, 2008
Primary CompletionOct 19, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.0 years ago

Interventions

E2007 (perampanel)drug

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.

E2007 (perampanel)drug

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.

Placebodrug

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.