EFFICACY AND TOLERABILITY STUDY OF UCB L059 IN PATIENTS WITH REFRACTORY EPILEPSY

We compared the experimental drug ucb L059 with placebo as an add-on t herapy in a single-blind, ascending-dose pilot study in 17 patients wi th refractory epilepsy. The dose of ucb L059 was increased every 4 wee ks by 500 mg in a stepwise fashion from 500 to 2,000 mg/day, and patie nts were assessed at weekly intervals for efficacy and safety evaluati on. Fourteen patients successfully completed 20 weeks of treatment wit h placebo and increasing doses of ucb L059. Three patients withdrew be cause of adverse events (AE) or lack of efficacy. Treatment with ucb L 059 was associated with a significant reduction in partial seizures as compared with baseline or placebo. Six patients experienced >50% redu ction in seizure frequency, and 3 others experienced a 25-50% reductio n. ucb L059 was well tolerated, only mild or moderate AE were reported , including drowsiness, memory-impairment, depression, and mood change s. No clinically significant changes in laboratory or safety evaluatio n was detected during treatment with ucb L059. A variable change in ph enytoin (PHT) and ucb L059 was noted, with PHT serum concentrations in creasing significantly in some patients. The results suggest that oral ucb L059 may be useful in the treatment of refractory partial epileps y.