Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures
This study has been completed.
Information provided by:
First received: May 17, 2006
Last updated: April 24, 2010
Last verified: September 2009
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Median % reduction - the median percentage change from baseline in seizure frequency during the maintenance period.
Secondary Outcome Measures:
- Response rate (%), the number of seizure-free days per 28 days, the median percent change of seizure-free days.
|Study Start Date:||September 2006|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
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 PLB group were titrated with placebo in the same way as in ZNS group.
Other Name: Zonegran
|Placebo Comparator: 2||Drug: Placebo|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327717
|The 1st hospital affiliated to Peking University|
|Beijing, Beijing, China, 100034|
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100730|
|Beijing Xuanwu Hospital|
|Beijing, Beijing, China|
|Huashan Hospital affiliated to Fudan University|
|Shanghai, Shanghai, China, 200040|
Sponsors and Collaborators
|Study Director:||Di Hong||Eisai China Inc.|