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Completed

NCT Number: NCT01127165

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dongsan Medical Center of Keimyung Univ., Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

zonisamide low dose group

Drug

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

zonisamide high dose group

Drug

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

Primary outcomes

  1. Percentage of Participants Who Were Assessed As Seizure Free

    Time frame: 24 weeks

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

Secondary outcomes

  1. Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)

    Time frame: Baseline and 24 weeks

    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.

  2. Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)

    Time frame: Baseline and 24 weeks

    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.

  3. Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)

    Time frame: Baseline and 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 20, 2010
Registry last updated
Jul 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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