CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 295 enrolled
Drug / intervention
Zonisamide +1 moredrug
Likely dose
Zonisamide 500 mgfrom 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/NCT00848549
NCT00848549Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind Extension Study To Assess The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures

Eisai Inc.·interventional·Posted Feb 20, 2009·Updated Dec 24, 2015

In Brief

A Phase 3 clinical trial evaluating Zonisamide and Carbamazepine for Epilepsy. Completed, enrolled 295 participants across 133 sites in 20 countries.

Detailed Summary

The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.

Study Details

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

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2009
Enrollment StartOct 1, 2008
Primary CompletionJun 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.4 years ago

Interventions

Zonisamidedrug

Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 500 mg; the minimum daily dose allowable is 200 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events, respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 100 mg per week.

Carbamazepinedrug

Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 1200 mg; the minimum daily dose allowable is 400 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 200 mg per week.