NCT01127256

Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Eisai Korea Inc. · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.

Detailed description

To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25\~27 weeks.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	zonisamide	Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.
DRUG	carbamazepine	Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.

Timeline

• Start date: 2006-05-31
• Primary completion: 2009-05-31
• Completion: 2009-07-31
• First posted: 2010-05-20
• Last updated: 2022-01-04
• Results posted: 2012-07-26

Locations

12 sites across 1 country: South Korea