A Multi-center Comparative Trial of Low and High Dose Zonisamide in Children with Newly Diagnosed Epilepsy as Monotherapy

INTERVENTION: Trade Name: Zonegran Product Name: zonisamide Product Code: E2090 Pharmaceutical Form: Tablet INN or Proposed INN: ZONISAMIDE CAS Number: 68291‐97‐4 Current Sponsor code: E2090 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 3‐8 CONDITION: Epilepsy Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy. Primary end point(s): Percentage of Participants Who Were Assessed As Seizure Free Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: 24 weeks SECONDARY OUTCOME: Secondary end point(s): Change in Cognitive Assessment Korean‐Wechsler Intelligence Scale for Children (K‐WISC‐III) ; ; Change in Behavior Assessment Korea‐Child Behavior Checklist (K‐CBCL) ; ; Change in Korean‐Quality of Life Childhood Epilepsy (K‐QOLCE) ; Timepoint(s) of evaluation of this end point: Baseline and 24 weeks INCLUSION CRITERIA: 1. Pediatric participants with epilepsy whose age is 2 15 years old. 2. Participants had at least two seizures for the last 6 months before entry. 3. Participants who had never taken antiepileptic drugs. 4. Participants with no chance of progressive disease based on the result of magnetic resonance imaging (MRI) or electroencephalogram (EEG). Are the trial subjects under 18? yes Number of subjects for this age range: 125 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range