CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 583 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/NCT00477295
NCT00477295Phase 3Completed
CompareCT.gov

A Randomized, Multi-centre, Double-blind Study, to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy

Eisai Inc.·interventional·Posted May 23, 2007·Updated Dec 24, 2015

In Brief

A Phase 3 clinical trial evaluating Zonisamide and Carbamazepine for Epilepsy. Completed, enrolled 583 participants across 79 sites in 18 countries.

Detailed Summary

This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing regime to allow optimal zonisamide or carbamazepine therapy for individual subjects. Assessment of eligibility will take place at the Screening Visit. The subjects will be randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1 must occur as soon as possible (and at least within 14 days) of the Screening Visit in order to optimize subject care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustralia, Denmark, France, Germany, Greece, Hungary, India, Italy, Poland, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 23, 2007
Enrollment StartMay 1, 2007
Primary CompletionDec 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 19.1 years ago

Interventions

Zonisamidedrug

Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.

Carbamazepinedrug

Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.