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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset...

Update Il y a 4 ans
Reference: EUCTR2008-007687-41

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset Seizures, Followed by an Open-Label Extension Study

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Extract

The primary objectives of this study are to compare the efficacy, safety, and tolerability of carisbamate as adjunctive treatment of partial onset seizures, relative to placebo, as measured by the: -Percent reduction in partial onset seizure frequency from baseline relative to the entire double blind treatment phase. -Responder rate from baseline relative to the entire double-blind treatment phase.

Inclusion criteria

  • Epilepsy with Partial Onset Seizures

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