FELBAMATE IN THE TREATMENT OF LENNOX-GASTAUT SYNDROME

Felbamate (FBM, Felbatol/Taloxa), a new antiepileptic drug (AED), was tested in a placebo-controlled add-on design in 73 patients with thera py refractory Lennox-Gastaut syndrome. Results of the efficacy analysi s showed that FBM was statistically significantly more effective (p < 0.05) than placebo for four of five predefined efficacy variables. The total number of seizures, for example, decreased by 26% during treatm ent with FBM compared with an increase of 5% during placebo (p < 0.001 ). Retrospective analysis of percentage of patients with specific resp onse rates confirmed results of the predefined efficacy variables. App roximately 50% of patients randomized to FBM obtained at least a 50% r eduction in seizure frequency compared with about 15% receiving placeb o. In addition, 12-month follow-up data in patients who completed the controlled part of the study confirmed the long-term efficacy of FBM. In general, FBM was well tolerated, with only gastrointestinal symptom s and somnolence seen more often with FBM compared with placebo. FBM i s the first compound shown to be effective in a controlled study in pa tients with Lennox-Gastaut syndrome.