Eisai Clinical Trials

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures

E2007-G000-332 CORE

Study Overview

E2007
perampanel
NCT01393743, EU CTR 2011-000265-12
Sep 2011 - May 2014
Primary Generalised Tonic Clonic Seizures
The primary efficacy endpoint was the percent change from baseline in PGTC seizure frequency per 28 days during treatment (Titration and Maintenance Periods combined), except for the purpose of European Union (EU) registration. The primary efficacy endpoint for the purpose of EU registration was the 50% responder rate (50% or greater reduction in PGTC seizure frequency during Maintenance Period relative to baseline).

  • Age 12+ males and females

  • Completed

  • Phase 3

  • Australia, Austria, China, Czech Republic, Estonia, France, Germany, Greece, Hungary, India, Israel, Japan, Korea, Republic of, Latvia, Lithuania, Netherlands, Poland, Serbia, Spain, Thailand, United States See more

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

French JA, Krauss GL, Wechsler RT, Wang XF, DiVentura B, Brandt C, Trinka E, O’Brien TJ, Laurenza A, Patten A, Bibbiani F. Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy A randomized trial. Neurology. 2015 Sep 15;85(11):950-7. DOI: 10.1212/WNL.0000000000001930

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