At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 343 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.
A Randomized, Open-label, Parallel Group, Multi-center, Comparative, Phase IV Trial of Levetiracetam (LEV) Versus Topiramate (TPM) as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
In Brief
A Phase 4 clinical trial evaluating Levetiracetam and Topiramate for Epilepsy. Completed, enrolled 343 participants across 24 sites.
Detailed Summary
To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesSouth Korea
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartNov 2010
Primary CompletionMay 2015
TodayJul 2026
First PostedOct 28, 2010
Enrollment StartNov 1, 2010
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 15.7 years ago
Interventions
Levetiracetamdrug
250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks
Topiramatedrug
25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks