Low and High Dose Zonisamide in Children as Monotherapy

NCT01127165 | Completed Phase 4 Results

• 1 other identifier: E2090-S082-404
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Were Assessed As Seizure Free

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

  24 weeks

Secondary Outcomes (3)

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

  Baseline and 24 weeks

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

  Baseline and 24 weeks

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

  Baseline and 24 weeks

Study Arms (2)

Zonisamide Low Dose Group

EXPERIMENTAL

Drug: zonisamide low dose group

Zonisamide High Dose group

EXPERIMENTAL

Drug: zonisamide high dose group

Interventions

zonisamide low dose group DRUG

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

Zonisamide Low Dose Group

zonisamide high dose group DRUG

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

Zonisamide High Dose group

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (11)

Dongsan Medical Center of Keimyung Univ.

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Inje Univ. Ilsan-Paik Hospital

Seoul, South Korea

Location

Inje Univ. Sanggye-Paik Hospital

Seoul, South Korea

Location

Korea Univ. Ansan Hospital

Seoul, South Korea

Location

Korea Univ. Guro Hospital

Seoul, South Korea

Location

National Health Insurance Corporation Ilsan Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Soonchunhyang Univ. Cheonan Hospital

Seoul, South Korea

Location

Soonchunhyang Univ. Hospital

Seoul, South Korea

Location

Yeungnam University Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Zonisamide; Population Groups

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Demography; Population Characteristics

Results Point of Contact

• Title: Jihee Mun, Pharmacist, Medical Department manager
• Organization: Eisai Korea Inc.

jihee_mun@eisaikorea.com

+82-2-3451-5531

Study Officials

• Jihee Mun

  Medical Department, Eisai Korea Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 20, 2010
• Study Start: March 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 31, 2012
• Results First Posted: July 31, 2012

Record last verified: 2010-05

Locations

KR (11)