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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...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-005098-37

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

Femme et Homme

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Extrait

STUDY 3013 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, for registration in the United States and the rest of the world (excluding the countries of Europe, Australia, New Zealand, and South Africa) · Responder rate from baseline relative to the entire double-blind treatment phase, for registration in the countries of Europe, Australia, New Zealand, and South Africa CARISEPY3014 To obtain long-term safety and tolerability data on subjects with partial onset seizures treated with open-label carisbamate

Critère d'inclusion

  • Partial onset seizure

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