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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects with Partial Onset S...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-003839-68

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects with Partial Onset Seizures Followed by an Open-Label Extension Study

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Extrait

The primary efficacy endpoint to be evaluated for registration in the United States and the Rest of the World is the percent reduction from the pretreatment baseline phase in seizure frequency (average monthly seizure rate per 28 days) of all simple partial motor, complex partial, or secondarilygeneralized seizures relative to the double-blind treatment phase. The primary efficacy endpoint to be evaluated for registration in the countries of Europe, Australia, New Zealand and South Africa is the responder rate.

Critère d'inclusion

  • Partial Onset Epilepsy Seizures

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