drugset / Trial / NCT01229735
Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-11
- Primary completion
- 2015-05
- Completion
- 2015-05
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Levetiracetam (Full Analysis Set) vs Topiramate (Full Analysis Set); p =0.7007; Odds Ratio (OR) 1.1 (95% CI 0.7 to 1.7); NCT01229735 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levetiracetam | Other / unclassified | 3000 mg | — |
| Comparator | Topiramate | Small molecule | 400 mg | — |