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-G000-306

Study Overview

E2007
perampanel
NCT00700310, EU CTR 2007-006169-33
Aug 2008 - Aug 2009
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.

  • Male or female and greater than or equal to 12 years of age or greater than or equal to 18 years of age depending on location

  • Completed

  • Phase 3

  • Australia, Bulgaria, Czech Republic, Estonia, Germany, Hong Kong, Hungary, India, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia and Montenegro, Spain, Taiwan, Thailand, Ukraine See more

Results

CSR Synopsis

No download available

Lay Summary

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Publication reference citation

Krauss GL, Serratosa JM, Villanueva V, Endziniene M, Hong Z, French J, et al. Randomized phase III study 306: adjunctive perampanel for refractory partial-onset seizures. Neurology 2012 May 01;78(18):1408-15. DOI: 10.1212/WNL.0b013e318254473a

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