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-G000-305

Study Overview

E2007
perampanel
NCT00699582, EU CTR 2007-006168-31
May 2008 - Dec 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 years and over)

  • Completed

  • Phase 3

  • Austria, Belgium, Finland, France, Germany, Greece, India, Israel, Italy, Netherlands, Russian Federation, South Africa, Sweden, United Kingdom, United States See more

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

French JA, Krauss GL, Steinhoff BJ, Squillacote D, Yang H, Kumar D, et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305. Epilepsia 2013 01;54(1):117-125. DOI: 10.1111/j.1528-1167.2012.03638.x

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