Abstracts

The purpose of this trial was to evaluate the efficacy and safety of levetiracetam (LEV) 3000 mg/d (b.i.d.) in patients with idiopathic generalised epilepsy experiencing myoclonic seizures. In this multicentre, placebo-controlled, double-blind trial, patients who were poorly controlled on one antiepileptic drug (AED) were randomised 1:1, LEV versus placebo. To be eligible, patients had to experience at least 8 days with myoclonic seizures during the 8-week prospective baseline. The 16-week treatment period was composed of a 4-week titration period followed by a 12-week stable dose evaluation period. Seizures were reported by the patients on diaries, myoclonic seizures and absence seizures being reported as days with seizures, while primary generalised tonic-clonic (PGTC) seizures were counted individually. The primary efficacy endpoint was the responder rate ([ge]50% reduction in days with myoclonic seizures during the treatment period versus baseline). 122 patients, aged 12-65 years, 113 with juvenile myoclonic epilepsy and 9 with juvenile absence epilepsy, were randomised. 60 LEV patients and 60 placebo patients were evaluable for efficacy and safety. The responder rate for myoclonic seizures was 58.3% with LEV versus 23.3% with placebo (p=0.0002). As a secondary analysis, for all seizure types, the median difference between groups in the percent reduction from baseline was obtained and compared using the Wilcoxon Mann Whitney test. The median difference in percent reduction in seizure days per week for all seizure types was 38.08 (LEV, n=60; placebo, n=60; p[lt]0.0001); for myoclonic seizures, it was 36.55 (LEV, n=60; placebo, n=60; p[lt]0.0001); and for absence seizures, it was 0 (LEV, n=19; placebo, n=17; p=not significant). The median difference in percent reduction in seizure frequency per week for PGTC seizures was 30.35 (LEV, n=15; placebo, n=18; p=not significant). LEV also demonstrated a good tolerability profile. LEV is highly efficacious and well tolerated in the treatment of refractory patients with idiopathic generalised epilepsy. LEV decreases the number of days with myoclonic seizures in a statistically and clinically significant manner. No significant difference was observed for absence and PGTC seizures. (Supported by funds from UCB.)