CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 712 enrolled
Drug / intervention
perampanel +3 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/NCT00700310
NCT00700310Phase 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 21, 2016

In Brief

A Phase 3 clinical trial evaluating perampanel and Placebo for Refractory Partial Seizures. Completed, enrolled 712 participants across 137 sites in 23 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety 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
CountriesAustralia, Bulgaria, Czechia, Estonia, Germany, Hong Kong, Hungary, India, Italy, Latvia, Lithuania, Malaysia, Philippines, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Taiwan, Thailand, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 18, 2008
Enrollment StartAug 1, 2008
Primary CompletionAug 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.0 years ago

Interventions

perampaneldrug

2 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.

perampaneldrug

4 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.

perampaneldrug

8 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.

Placebodrug

Placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily.