drugset / Trial / NCT01498822

Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy

NCT01498822

Phase 4 Completed 353 enrolled UCB Pharma
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2011-06
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Levetiracetam Other / unclassified 1000 mg
Subject Levetiracetam Other / unclassified 3000 mg
Comparator Oxcarbazepine Small molecule 900 mg
Comparator Oxcarbazepine Small molecule 2400 mg

Indications