NCT00327717

Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures

A Multicenter, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Partial Seizures

Interventions

Type	Name	Description
DRUG	Zonisamide	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.
DRUG	Placebo	Patients in placebo group were titrated with placebo in the same way as in zonisamide group.

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2006-05-18
• Last updated: 2014-08-15
• Results posted: 2014-08-15

Locations

8 sites across 1 country: China