NCT00693017

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

A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Zonisamide	50-400 mg capsules once daily in the evening orally. Maximum study duration 28 weeks comprising: Baseline Period (Week -8 to Week 0): no treatment Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events) Down Titration Period (4 Weeks)
DRUG	Placebo	50-400 mg Zonisamide Placebo capsules once daily in the evening orally. Maximum study duration 28 weeks comprising: Baseline Period (Week -8 to Week 0): no treatment Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events) Down Titration Period (4 Weeks)

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-11-01
• First posted: 2008-06-06
• Last updated: 2015-12-24
• Results posted: 2012-09-12

Locations

72 sites across 13 countries: Australia, Croatia, Czechia, Estonia, Finland, Germany, Hungary, Lithuania, Poland, Romania, Russia, Serbia, Ukraine