Comparison of levetiracetam and oxcarbazepine monotherapy among Korean patients with newly diagnosed focal epilepsy: A long‐term, randomized, open‐label trial

Summary This open‐label, multicenter, randomized phase IV trial ( NCT 01498822) of noninferiority design compared the long‐term effectiveness, safety, and tolerability of levetiracetam ( LEV ) monotherapy with those of oxcarbazepine ( OXC ) monotherapy in adults with newly diagnosed focal epilepsy. Korean patients (16–80 years), with ≥2 unprovoked focal seizures in the year preceding the trial, who had not taken any antiepileptic drugs ( AED s) in the last 6 months, were randomized to receive LEV or OXC (1:1). Effectiveness, safety, and tolerability were assessed over a 50‐week period. Treatment failure rates (per protocol set) were 15/118 (12.7%) in the LEV ‐treated group and 30/128 (23.4%) in the OXC ‐treated group, an absolute difference of −10.7% (95% confidence interval [ CI ] −20.2, −1.2). Because the upper 95% CI limit was less than the pre‐specified noninferiority margin of 15%, LEV was considered noninferior to OXC . Twenty‐four‐week and 48‐week seizure freedom rates were 53.8% and 34.7% for LEV vs. 58.5% and 40.9% for OXC . Both LEV and OXC were well tolerated, with 8.7% and 8.6% of patients reporting serious treatment‐emergent adverse events, respectively. By comparing LEV with OXC , another newer AED , LEV can be considered a useful option as initial monotherapy for patients with newly diagnosed focal epilepsy.