Low and High Dose Zonisamide in Children as Monotherapy

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

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

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: zonisamide low dose group; Drug: zonisamide high dose group

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Korea Univ. Guro hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Dongsan Medical Center of Keimyung Univ.
  • Seoul, Korea, Republic of
    • Inje Univ. Ilsan-Paik Hospital
  • Seoul, Korea, Republic of
    • Inje Univ. Sanggye-Paik Hospital
  • Seoul, Korea, Republic of
    • Korea Univ. Ansan Hospital
  • Seoul, Korea, Republic of
    • National Health Insurance Corporation Ilsan Hospital
  • Seoul, Korea, Republic of
    • Soonchunhyang Univ. Cheonan Hospital
  • Seoul, Korea, Republic of
    • Soonchunhyang Univ. Hospital
  • Seoul, Korea, Republic of
    • Yeungnam University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eisai Korea Inc.
• Investigators: Study Director: Jihee Mun, Medical Department, Eisai Korea Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: May 19, 2010
• First Submitted That Met QC Criteria: May 19, 2010
• First Posted (Estimate): May 20, 2010

Study Record Updates

• Last Update Posted (Estimate): July 31, 2012
• Last Update Submitted That Met QC Criteria: June 25, 2012
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Zonisamide
• Other Study ID Numbers: E2090-S082-404