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

PHASE3CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

Conditions
Partial Seizures
Interventions
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.

Trial Locations (8)

100034

Peking University First Hospital, Beijing

100053

Peking Union Hospital, Beijing

100730

Peking Union Medical College Hospital, Beijing

200003

Shanghai Changzheng Hospital, Shanghai

200040

Shanghai Hua-shan Hospital, Shanghai

400016

The First Affiliated Hospital of Chongqing Medical University, Chongqing

610041

Chengdu Huaxi Hospital, Chengdu

710032

XiÆan Xijing Hospital, XiÆan

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT00327717 - Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures | Biotech Hunter | Biotech Hunter