Low and High Dose Zonisamide in Children as Monotherapy

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127165
• Other study ID #: E2090-S082-404
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2010
• Last updated: June 25, 2012
• Start date: March 2006
• Est. completion date: July 2009

Study information

• Verified date: May 2010
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 15 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• zonisamide low dose group
Initial dose was 2mg/kg/day, increased after 1~2 weeks to 3~4mg/kg/day.
• zonisamide high dose group
Initial dose was 2mg/kg/day, increased after 2~4 weeks to 6~8mg/kg/day.

Locations

Country	Name	City	State
Korea, Republic of	Dongsan Medical Center of Keimyung Univ.	Seoul
Korea, Republic of	Gangnam Severance Hospital	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	Korea Univ. Guro Hospital	Seoul
Korea, Republic of	National Health Insurance Corporation Ilsan Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Soonchunhyang Univ. Cheonan Hospital	Seoul
Korea, Republic of	Soonchunhyang Univ. Hospital	Seoul
Korea, Republic of	Yeungnam University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Were Assessed As Seizure Free	The percentage of participants who showed no seizure during the maintenance phase.	24 weeks	No
Secondary	Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-?)	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	No
Secondary	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	No
Secondary	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	No