Conditions: Epilepsy
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 121
Healthy volunteers: no

Brief summary:
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.

Detailed description:
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.

Arms:
arm 1: None

Interventions: intervention 1: zonisamide
Intervention descriptions: intervention 1: zonisamide 100 mg tablet

Protocol document: