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 EXT

Study Overview

E2007
perampanel
NCT01393743, EU CTR 2011-000265-12
Sep 2011 - May 2014
Seizure Disorder Generalized Tonic Clonic
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).

  • Males and females (age 12 years and over)

  • Completed

  • Phase 3

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

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Wechsler et al (2016) Long-term Safety and Efficacy of Adjunctive Perampanel in Patients with Drug-resistant Primary Generalised Tonic-clonic Seizures in Idiopathic Generalised Epilepsy: Results of an Open-label Extension. Poster presented at the 12th European Congress on Epileptology, Prague, Czech Republic, 11–15 September 2016 (P555)

Long-term safety and efficacy outcomes of adjunctive perampanel: an open-label extension (OLEx) of a Phase III study in patients with drug-resistant primary generalized tonic-clonic (PGTC) seizures in idiopathic generalized epilepsy (IGE) (P5.233). Robert T Wechsler, Jacqueline French, Eugen Trinka, Christian Brandt, Terence O’Brien, Francesco Bibbiani, Anna Patten, Antonio Laurenza. Neurology Apr 2017, 88 (16 Supplement) P5.233; https://n.neurology.org/content/88/16_Supplement/P5.233

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