drugset / Trial / NCT01229735

Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

NCT01229735 ↗

Phase 4 Completed 343 enrolled UCB Pharma
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

EvaluationDrugModalityDoseRoute
Subject Levetiracetam Other / unclassified 3000 mg —
Comparator Topiramate Small molecule 400 mg —

Indications