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 moreSee less
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
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Redacted documents are available upon request for this study.