CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
zonisamide +1 moredrug
Likely dose
zonisamide 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01127256
NCT01127256Phase 4Completed

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

Eisai Korea Inc.·interventional·Posted May 20, 2010·Updated Jan 4, 2022

In Brief

A Phase 4 clinical trial evaluating zonisamide and carbamazepine for Epilepsy. Completed, enrolled 200 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 20, 2010
Enrollment StartMay 31, 2006
Primary CompletionMay 31, 2009
Study CompletionJul 31, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.1 years ago

Interventions

zonisamidedrug

Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.

carbamazepinedrug

Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.