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

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

Outcome

Met primary endpoint

paper Because the upper 95% CI limit was less than the pre-specified noninferiority margin of 15%, LEV was considered noninferior to OXC. PMID 28395124 ↗

Publications

Kim JH, Lee SK, Loesch C, Namgoong K, Lee HW, Hong SB; Korean N01367 Study Group. Comparison of levetiracetam and oxcarbazepine monotherapy among Korean patients with newly diagnosed focal epilepsy: A long-term, randomized, open-label trial. Epilepsia. 2017 Apr;58(4):e70-e74. doi: 10.1111/epi.13707.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levetiracetam	Other / unclassified	1000 mg	—
Subject	Levetiracetam	Other / unclassified	3000 mg	—
Comparator	Oxcarbazepine	Small molecule	900 mg	—
Comparator	Oxcarbazepine	Small molecule	2400 mg	—