The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100 \~ 400 mg/day and target dose is 300 mg/day. After 16 weeks, zonisamide efficacy is measured by seizure reduction rate (Each type of seizure: simple partial seizures \[SPS\], complex partial seizures \[CPS\], simple partial seizures evolving into generalized tonic-clonic convulsions \[SGTC\] and total seizure frequency), seizure free rate, responder rate, quality of life in epilepsy (QOLIE-31) and investigator's global evaluation scale. Safety of zonisamide in this study will be estimated by adverse event profile, retention rate and dose of exposure. The duration of this clinical study is 2 years including period of subject enrollment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
zonisamide 100 mg tablet
Dong-A University Hospital, Dept. of Neurology
Busan, South Korea
Inje Univ. Pusan Paik Hospital, Dept. of Neurology
Busan, South Korea
Keimyung Univ.Dongsan Medical Centre, Dept. of Neurology
Daegu, South Korea
Seizure Reduction Rate
The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.
Time frame: Baseline and 16 weeks
Seizure Free Rate
The percentage of the participants who experienced no seizure during the trial.
Time frame: 16 weeks
Responder Rate
The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.
Time frame: Baseline and 16 weeks
QoL-QOLIE31 (Quality of Life in Epilepsy)
Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.
Time frame: Baseline and 16 weeks
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Kyungpook Natl. Univ. Hosp., Dept. of Neurology
Daegu, South Korea
Yeungnam Univ. Medical Center, Dept. of Neurology
Daegu, South Korea
Gachon Medical School Gil Medical Centre, Dept.of Neurology
Incheon, South Korea
Natl. Health Insurance Corporation Ilsan Hosp., Dept. of Neurology
Koyang, South Korea
Bundang CHA Hospital, Dept. of Neurology
Seongnam, South Korea
Kangdong Sacred Heart Hosp., Dept. of Neurology
Seoul, South Korea
Severance Hospital, Dept. of Neurology
Seoul, South Korea