The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Tablet once or twice daily orally for 16 weeks
Tablet once daily orally for 16 weeks
Changhua Christian Hospital
Changhua, Taiwan, China
Chang-Gung Memorial Hospital (CGMH)
Kaohsiung, Taiwan, China
Chang-Gung Memorial Hospital (CGMH)
Linkou, Taiwan, China
China Medical University Hospital (CMUH)
Taichun, Taiwan, China
The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline
Percentage Change of Frequency = (T-B)/B\*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)\* 4 B= The monthly seizure frequence with one month prior to enrollment
Time frame: Baseline and 16 weeks
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period
Time frame: Baseline and 16 weeks
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period
Time frame: Baseline and 16 weeks
Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.
Time frame: Baseline and 16 weeks
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National Cheng Kung University Hospital
Tainan, Taiwan, China
Chang-Gung Memorial Hospital (CGMH)
Taipei, Taiwan, China
Taipei Tzu Chi General Hospital
Taipei, Taiwan, China
Taipei Veterans General Hospital
Taipei, Taiwan, China