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Low and High Dose Zonisamide in Children as Monotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier:
NCT01127165
First received: May 19, 2010
Last updated: June 25, 2012
Last verified: May 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Epilepsy
 Drug: zonisamide low dose group
Drug: zonisamide high dose group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Comparative Trial of Low and High Dose Zonisamide in Children as Monotherapy

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
Drug Information available for: Zonisamide
U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Percentage of Participants Who Were Assessed As Seizure Free [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The percentage of participants who showed no seizure during the maintenance phase.


Secondary Outcome Measures:
  • Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 125
Study Start Date: March 2006
Study Completion Date: July 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   2 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127165

Locations
Korea, Republic of
Yeungnam University Medical Center
Seoul, Korea, Republic of
Dongsan Medical Center of Keimyung Univ.
Seoul, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
Seoul, Korea, Republic of
Korea Univ. Guro Hospital
Seoul, Korea, Republic of
Korea Univ. Ansan Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Inje Univ. Sanggye-Paik Hospital
Seoul, Korea, Republic of
Inje Univ. Ilsan-Paik Hospital
Seoul, Korea, Republic of
Soonchunhyang Univ. Hospital
Seoul, Korea, Republic of
Soonchunhyang Univ. Cheonan Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Eisai Korea Inc.
Investigators
Study Director: Jihee Mun Medical Department, Eisai Korea Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier: NCT01127165     History of Changes
Other Study ID Numbers: E2090-S082-404
Study First Received: May 19, 2010
Results First Received: July 29, 2010
Last Updated: June 25, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Zonisamide
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013