Eisai Clinical Trials

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

E2007-G000-304

Study Overview

E2007
perampanel
NCT00699972, EU CTR 2007-006191-11
Jun 2008 - Oct 2010
Refractory Partial Seizures
The primary efficacy endpoint was the percent change in seizure frequency per 28 days during treatment relative to baseline, except for the purpose of European Union (EU) registration. The primary efficacy endpoint for the purpose of EU registration was the 50% responder rate.

  • Males and females (age 12 and over)

  • Completed

  • Phase 3

  • Argentina, Canada, Chile, Mexico, United States See more

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

French JA, Krauss GL, Biton V, Squillacote D, Yang H, Laurenza A, et al. Adjunctive perampanel for refractory partial-onset seizures: Randomized phase III study 304. Neurology 2012 Aug 07;79(6):589-596. DOI: 10.1212/WNL.0b013e3182635735

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

Redacted documents are available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR