Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures
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|ClinicalTrials.gov Identifier: NCT00327717|
Recruitment Status : Completed
First Posted : May 18, 2006
Results First Posted : August 15, 2014
Last Update Posted : August 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Partial Seizures||Drug: Zonisamide Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
|Experimental: Zonisamide 100 mg tablet||
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.
Other Name: Zonegran
|Placebo Comparator: Placebo||
Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
- Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures (SGS)) During the Fixed-dose Phase [ Time Frame: Baseline and 16 weeks ]The median percent change in seizure frequency of all partial seizures (CP+SP+SGS) from baseline during the fixed-dose phase.
- The Mean Percent Change From Baseline in Complex Partial (CP) Seizure Frequency [ Time Frame: Baseline and 16 weeks ]The Mean Percent Change in seizure frequency of CP from baseline during the fixed-dose phase.
- The Mean Percent Change From Baseline in Simple Partial (SP) Seizure Frequency [ Time Frame: Baseline and 16 weeks ]The Mean percent change in seizure frequency of SP from baseline during the fixed-dose phase.
- The Mean Percent Change From Baseline in Partial Seizures With Secondary Generalization (SGS) [ Time Frame: Baseline and 16 weeks ]The mean percent change in seizure frequency of SGS from baseline during the fixed-dose phase.
- Responder Rate [ Time Frame: Baseline and 16 weeks ]Responder rate is defined as percentage of participants with >=50% reduction in seizure frequency from baseline.
- Mean Number of Seizure Free Days [ Time Frame: 12 weeks ]Mean number of seizure free days per 28 day period during fixed dose phase
- Mean Percentage of Change in Seizure Free Days [ Time Frame: 16 weeks ]
- Mean Time to First Seizure (Days) [ Time Frame: 16 weeks ]Mean time to first seizure during fixed dose phase
- Percentage of Seizure-free Participants During Fixed-dose Phase [ Time Frame: 16 weeks ]Percentage of seizure-free participants during fixed-dose phase
- Drop - Out Rate [ Time Frame: 16 weeks ]Number of Participants who dropped out of the study. In the Study drop-out rate is defined as number of participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327717
|Peking University First Hospital|
|Beijing, Beijing, China, 100034|
|Peking Union Hospital|
|Beijing, Beijing, China, 100053|
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100730|
|The First Affiliated Hospital of Chongqing Medical University|
|Chongqing, Chongqing, China, 400016|
|Shanghai Changzheng Hospital|
|Shanghai, Shanghai, China, 200003|
|Shanghai Hua-shan Hospital|
|Shanghai, Shanghai, China, 200040|
|XiÆan Xijing Hospital|
|XiÆan, Shanxi, China, 710032|
|Chengdu Huaxi Hospital|
|Chengdu, Sichuan, China, 610041|
|Study Director:||Di Hong||Eisai China Inc.|