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Low and High Dose Zonisamide in Children as Monotherapy

NCT01127165 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2012-07-31

Study results available
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Summary

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

Conditions

Interventions

DRUG

zonisamide low dose group

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

DRUG

zonisamide high dose group

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

Sponsors & Collaborators

  • Eisai Korea Inc.

    lead INDUSTRY

Principal Investigators

  • Jihee Mun · Medical Department, Eisai Korea Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2009-03-31
Completion
2009-07-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01127165 on ClinicalTrials.gov