NCT01127165

Low and High Dose Zonisamide in Children as Monotherapy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Eisai Korea Inc. · Industry
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Epilepsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-03-01
• Primary completion: 2009-03-01
• Completion: 2009-07-01
• First posted: 2010-05-20
• Last updated: 2012-07-31
• Results posted: 2012-07-31

Locations

11 sites across 1 country: South Korea