NCT00692003

Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures

A Double-blind, Randomised, Placebo-controlled Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: 6 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of primary generalised tonic-clonic seizures. The total trial duration will be 5.5-6.5 months. After that subjects who have completed the study will be eligible to enrol 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-E044-316).

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Zonisamide	25-400 mg capsules orally once daily in the evening. Maximum study duration of 28 weeks comprising: Baseline Period (Week-8/-4 to Week 0) no treatment Titration Period (Week 0 to Week 4) \<12 years old: 1 mg/kg; \>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events) Down Titration Period (4 weeks)
DRUG	Placebo	25-400 mg Zonisamide Placebo capsules orally once daily in the evening. Maximum study duration of 28 weeks comprising: Baseline Period (Week-8/-4 to Week 0) no treatment Titration Period (Week 0 to Week 4) \<12 years old: 1 mg/kg Zonisamide Placebo; \>= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events) Down Titration Period (4 weeks)

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-11-01
• Completion: 2009-01-09
• First posted: 2008-06-06
• Last updated: 2017-03-14
• Results posted: 2012-10-12

Locations

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