Low and High Dose Zonisamide in Children as Monotherapy

Study Overview
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Brief Summary
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The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.

Official Title
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A Multi-center Comparative Trial of Low and High Dose Zonisamide in Children as Monotherapy

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: zonisamide low dose group
* Drug: zonisamide high dose group


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Pediatric patients with epilepsy whose age is 2 15 years old. Patients had at least two seizures for the last 6 months before entry. Patients who had never taken antiepileptic drugs. Patients with no chance of progressive disease based on the result of magnetic resonance imaging (MRI) or electroencephalogram (EEG). Agreement of the guardian is needed. Exclusion criteria: Patients who have progressive central nervous system (CNS) disease. Patients with serious disorder. Patients who have abnormal liver function (serum glutamic oxaloacetic transaminase [SGOT]) or (serum glutamic pyruvic transaminase [SGPT]) values more than twice the normal values. Patients who have abnormal renal function (blood urea nitrogen (BUN) or Creatinine) values more than three times the normal values. Hemolytic anemia.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zonisamide Low Dose Group<br> | Drug: zonisamide low dose group<br>* Initial dose was 2mg/kg/day, increased after 1 2 weeks to 3 4mg/kg/day.<br>|
| Experimental: Zonisamide High Dose group<br> | Drug: zonisamide high dose group<br>* Initial dose was 2mg/kg/day, increased after 2 4 weeks to 6 8mg/kg/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Were Assessed As Seizure Free | The percentage of participants who showed no seizure during the maintenance phase. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ) | Cognitive assessment was performed using K-WISC-III. The total score of K-WISC-III is calculated as Full Scale IQ which ranges from 31 (worst) to 151(best). Higher scores indicate greater intelligence, lower scores indicate less intelligence. Thus a positive change indicated an improvement. | Baseline and 24 weeks | 
| Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL) | The difference of K-CBCL between before and after the administration. K-CBCL is the Korean version of CBCL which is a standardized form that parents fill out to describe their children's behavioral and emotional problems. The total score ranges 0- 234, with higher scores indicating worse behavioral and emotional problems. | Baseline and 24 weeks | 
| Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE) | The difference of K-QOLCE between before and after the administration. K-QOLCE is Korean version of the Quality of Life in Childhood Epilepsy Questionnaire. The calculated total score ranges 0-100, with higher scores indicating higher quality of life. | Baseline and 24 weeks |