Low and High Dose Zonisamide in Children as Monotherapy

Phase 4

Completed

• Conditions: Epilepsy
• Interventions: Drug: zonisamide low dose group; Drug: zonisamide high dose group

• Registration Number: NCT01127165
• Lead Sponsor: Eisai Korea Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2009-03
• Study Completion: 2009-07
• Status Verified: 2010-05
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Results First Submitted: 2010-07-29
• Results First Submitted QC: 2012-06-25
• Last Update Submitted: 2012-06-25
• Results First Posted: 2012-07-31
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zonisamide Low Dose Group	zonisamide low dose group	-
Zonisamide High Dose group	zonisamide high dose group	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Were Assessed As Seizure Free	24 weeks	The percentage of participants who showed no seizure during the maintenance phase.

Secondary Outcome Measures

Name	Time	Method
Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)	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.
Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)	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.
Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)	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.

Trial Locations

Locations (11)

Korea Univ. Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Dongsan Medical Center of Keimyung Univ.; 🇰🇷 Seoul, Korea, Republic of

Inje Univ. Ilsan-Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Inje Univ. Sanggye-Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang Univ. Cheonan 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. Hospital; 🇰🇷 Seoul, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Seoul, Korea, Republic of