Conditions: Partial Seizures
Keywords: Epilepsy Partial seizures
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 240
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Zonisamide intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: Patients in placebo group were titrated with placebo in the same way as in zonisamide group.

Protocol document: