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

Phase 4

Completed

• Conditions: Epilepsy
• Interventions: Drug: zonisamide; Drug: carbamazepine

• Registration Number: NCT01127256
• Lead Sponsor: Eisai Korea Inc.

Brief 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.

Study Timeline

• Study Start: 2006-05-31
• Primary Completion: 2009-05-31
• Study Completion: 2009-07-31
• Status Verified: 2010-05
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Results First Submitted: 2010-08-02
• Results First Submitted QC: 2012-06-20
• Results First Posted: 2012-07-26
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	zonisamide	-
2	carbamazepine	-

Primary Outcome Measures

Name	Time	Method
The Percentage of Participants With Seizure Free Rate	24 weeks	The percentage of participants who had no seizure during the trial.

Secondary Outcome Measures

Name	Time	Method
The Percentage of Participants With Retention Rate	24 weeks	The percentage of participants who completed the trial.
Quality of Life in Epilepsy (QoL-QOLIE31)	24 weeks	Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.

Trial Locations

Locations (12)

Seoul National Univ. Bundang Hosp.; 🇰🇷 Bundang, Korea, Republic of

Dongguk Univ. Ilsan Hosp.; 🇰🇷 Ilsan, Korea, Republic of

Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Ewha Womans Univ. Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of

Hallym Univ. Medical Center; 🇰🇷 Seoul, Korea, Republic of

Hanyang Univ. Medical Center; 🇰🇷 Seoul, Korea, Republic of

Konkuk Univ. Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National Univ. Hosp.; 🇰🇷 Seoul, Korea, Republic of

Eulji General Hosp.; 🇰🇷 Seoul, Korea, Republic of

Chungnam National Univ. Hosp.; 🇰🇷 Chungnam, Korea, Republic of

Inha Univ. Hosp.; 🇰🇷 Incheon, Korea, Republic of