drugset / Trial / NCT00693017

Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy

NCT00693017

Phase 3 Terminated 10 enrolled Eisai Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is intended to provide evidence that zonisamide is safe and effective in the treatment of myoclonic seizures. The total planned trial duration will be 6.5 months. After that, subjects who have completed the study will be eligible to enroll in an open-label extension study until zonisamide is marketed for this indication or further development in this indication stops. This extension study will be described in a separate protocol (E2090-E044-318).

Timeline

Start
2008-06
Primary completion
2008-11
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Zonisamide Other / unclassified 350 mg Oral
Comparator Zonisamide Other / unclassified 400 mg Oral

Indications