At a glance
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A Multicenter, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures
In Brief
A Phase 3 clinical trial evaluating Zonisamide and Placebo for Partial Seizures. Completed, enrolled 240 participants across 8 sites.
Detailed Summary
The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as adjunctive therapy in medically refractory patients receiving other antiepileptic drugs (AEDs).
Study Details
Timeline
Interventions
Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
Patients in placebo group were titrated with placebo in the same way as in zonisamide group.