Low and High Dose Zonisamide in Children as Monotherapy

Phase 4CompletedNCT01127165

Eisai Korea Inc.125 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

Epilepsy

Interventions

zonisamide low dose groupDRUG

Initial dose was 2mg/kg/day, increased after 1\~2 weeks to 3\~4mg/kg/day.

zonisamide high dose groupDRUG

Initial dose was 2mg/kg/day, increased after 2\~4 weeks to 6\~8mg/kg/day.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Pediatric patients with epilepsy whose age is 2\~15 years old. 2. Patients had at least two seizures for the last 6 months before entry. 3. Patients who had never taken antiepileptic drugs. 4. Patients with no chance of progressive disease based on the result of magnetic resonance imaging (MRI) or electroencephalogram (EEG). 5. Agreement of the guardian is needed. Exclusion criteria: 1. Patients who have progressive central nervous system (CNS) disease. 2. Patients with serious disorder. 3. Patients who have abnormal liver function (serum glutamic oxaloacetic transaminase \[SGOT\]) or (serum glutamic pyruvic transaminase \[SGPT\]) values more than twice the normal values. 4. Patients who have abnormal renal function (blood urea nitrogen (BUN) or Creatinine) values more than three times the normal values. 5. Hemolytic anemia.

Locations (11)

Dongsan Medical Center of Keimyung Univ.

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Inje Univ. Ilsan-Paik Hospital

Seoul, South Korea

Inje Univ. Sanggye-Paik Hospital

Outcomes

Primary Outcomes

Percentage of Participants Who Were Assessed As Seizure Free

The percentage of participants who showed no seizure during the maintenance phase.

Time frame: 24 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and 24 weeks

Data from ClinicalTrials.gov

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