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 moreSee less
Results
CSR Synopsis
No download available
Lay Summary
No download available
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
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Redacted documents are available upon request for this study.