Efficacy and tolerability study of ucb L059 in patients with refractory epilepsy

Abstract

We compared the experimental drug ucb L059 with placebo as an add-on therapy in a single-blind, ascending-dose pilot study in 17 patients with refractory epilepsy. The dose of ucb L059 was increased every 4 weeks by 500 mg in a stepwise fashion from 500 to 2,000 mg/day, and patients were assessed at weekly intervals for efficacy and safety evaluation. Fourteen patients successfully completed 20 weeks of treatment with placebo and increasing doses of ucb L059. Three patients withdrew because of adverse events (AE) or lack of efficacy. Treatment with ucb L059 was associated with a significant reduction in partial seizures as compared with baseline or placebo. Six patients experienced >50% reduction in seizure frequency, and 3 others experienced a 25–50% reduction. ucb L059 was well tolerated, only mild or moderate AE were reported, including drowsiness, memory impairment, depression, and mood changes. No clinically significant changes in laboratory or safety evaluation was detected during treatment with ucb L059. A variable change in phenytoin (PHT) and ucb L059 was noted, with PHT serum concentrations increasing significantly in some patients. The results suggest that oral ucb L059 may be useful in the treatment of refractory partial epilepsy.