Conditions: Epilepsy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 41
Healthy volunteers: no

Brief summary:
A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will be administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (AEDs).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Zonisamide at targeted daily doses of 100-500 mg/day intervention 2: Placebo administered to match targeted daily doses of 100-500 mg/day
Intervention descriptions: intervention 1: Each group received 2 doses a day (in the morning and evening) during the Titration Period, once a day (in the evening) or BID during the Maintenance Phase, comprising 25 mg, 50 mg, or 100 mg of ZNS capsules intervention 2: matching placebo

Protocol document: