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Low and High Dose Zonisamide in Children as Monotherapy

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
zonisamide low dose group
zonisamide high dose group
Sponsored by
Eisai Korea Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

2 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Zonisamide Low Dose Group

Zonisamide High Dose group

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Who Were Assessed As Seizure Free
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)
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)
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)
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.

Full Information

First Posted
May 19, 2010
Last Updated
June 25, 2012
Sponsor
Eisai Korea Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01127165
Brief Title
Low and High Dose Zonisamide in Children as Monotherapy
Official Title
A Multi-center Comparative Trial of Low and High Dose Zonisamide in Children as Monotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Korea Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zonisamide Low Dose Group
Arm Type
Experimental
Arm Title
Zonisamide High Dose group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
zonisamide low dose group
Intervention Description
Initial dose was 2mg/kg/day, increased after 1~2 weeks to 3~4mg/kg/day.
Intervention Type
Drug
Intervention Name(s)
zonisamide high dose group
Intervention Description
Initial dose was 2mg/kg/day, increased after 2~4 weeks to 6~8mg/kg/day.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Were Assessed As Seizure Free
Description
The percentage of participants who showed no seizure during the maintenance phase.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)
Description
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
Title
Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)
Description
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
Title
Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihee Mun
Organizational Affiliation
Medical Department, Eisai Korea Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dongsan Medical Center of Keimyung Univ.
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Inje Univ. Ilsan-Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Inje Univ. Sanggye-Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Univ. Ansan Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Univ. Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
National Health Insurance Corporation Ilsan Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Soonchunhyang Univ. Cheonan Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Soonchunhyang Univ. Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Low and High Dose Zonisamide in Children as Monotherapy

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