Clinical Trial: Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Gen
Brief 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).
Detailed Summary:
Sponsor: Eisai Limited
Current Primary Outcome: Number of Participants Considered Responders as Assessed During the Maintenance Period [ Time Frame: Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16) ]
Original Primary Outcome: Proportion of responders as assessed during the maintenance phase. [ Time Frame: 12 weeks ]
Current Secondary Outcome: Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures [ Time Frame: Baseline and up to 16 weeks ]
Original Secondary Outcome: Percentage change from baseline in the monthly number of days with myoclonic seizures; AEs, SAEs; incidence of Treatment Emergent Adverse Events (TEAEs); physical and neurological examinations; vital signs; clinical lab tests; weight, height; ECGs. [ Time Frame: 12 weeks ]
Information By: Eisai Inc.
Dates:
Date Received: June 3, 2008
Date Started: June 2008
Date Completion:
Last Updated: December 21, 2015
Last Verified: November 2015