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) ]

The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease >= 50% from baseline in the number of days with myoclonic seizures per 28 days (i.e. 28-day myoclonic seizure frequency in Period from Week 4 to the Week 16 visit compared to Week -8 to randomization at Week 0 [Screening/ Baseline Period]). Occurrence of seizures was documented in a seizure diary. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) and reviewed at each following visit. The diary was completed daily. All seizures except myoclonic seizures were counted individually in the the diary. Due to early termination of the study by the Sponsor, no formal analyses were conducted.


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 ]

Percentage Change from Baseline in the monthly number of days with myoclonic seizures was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16). Due to early termination of the study by the Sponsor, no formal analyses were conducted.


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