CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 353 enrolled
Drug / intervention
Levetiracetam +1 moredrug
Likely dose
Levetiracetam 250 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/NCT01498822
NCT01498822Phase 4Completed
CompareCT.gov

A Multi-Center, Open-label, Randomized Study to Evaluate the Long Term Effectiveness of Levetiracetam as Monotherapy in Comparison With Oxcarbazepine in Subjects With Newly or Recently Diagnosed Partial Epilepsy

Korea UCB Co., Ltd.·interventional·Posted Dec 23, 2011·Updated Aug 20, 2015

In Brief

A Phase 4 clinical trial evaluating Levetiracetam and Oxcarbazepine for Epilepsy. Completed, enrolled 353 participants across 23 sites.

Detailed Summary

To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment Failure Rate in subjects with newly diagnosed partial onset seizures with or without secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks from the first dose

Study Details

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

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 23, 2011
Enrollment StartJun 1, 2011
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.5 years ago

Interventions

Levetiracetamdrug

250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks

Oxcarbazepinedrug

150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1week then 600 mg/day 1 week)