Felbamate (FBM) is marketed for the treatment of Lennox-Gastaut syndrome. Many reports referred the efficacy in partial epilepsy. FBM add-on treatment was evaluated in 42 patients with severe refractory epilepsy (38 partial epilepsy. 4 Lennox-Gastaut syndrome) in an open-label trial. FBM was titrated up to the satisfactory clinical control or the maximal tolerated dose, not exceeding 3600 mg/day (3064 ±834). Blood parameters of liver and bone marrow functions were checked at recruitment and every fortnight after FBM was added. A >509l increase of serum values of transaminases and/or alkaline phosphatase. and/or a reduction 2000) of white cells caused the FBM withdrawal. The primary efficacy variables were the mean monthly seizure frequency calculated on a three-month basis and compared versus baseline, and the number of seizure-free patients. Thirty-two patients with at least 3-month follow-up have been included in the efficacy evaluation. No change in mean seizure frequency vs. baseline was found in partial as well as generalized seizures: 6 patients showed a seizure reduction greater than S09i and 2 were seizure-free over a period ranging 12 to 24 months. All patients have been included in the tolerability analysis. Ten dropped-out in the first quarter (8 because of adverse effects, 2 for personal reasons). In 3 cases an increase of serum transaminases and alkaline phosphatase, promptly disappeared after FBM withdrawal, was found. Twenty-seven patients experienced side effects: drowsiness (20.4'/r ). stomach ache (14.2%), and weight loss >5% (9.59l ) were the most frequent side effects. The FBM in this open-label long-term study performed in severe refractory epilepsies showed efficacy in a wide range of seizures. Monitoring liver and bone marrow functions permits a sufficient safety.
|Number of pages||1|
|Journal||Italian Journal of Neurological Sciences|
|Publication status||Published - 1999|
ASJC Scopus subject areas
- Clinical Neurology