EFFECT OF SABELUZOLE (R-58-735) ON MEMORY FUNCTIONS IN PATIENTS WITH EPILEPSY

Sabeluzole, a new benzothiazol derivative, has shown positive effects on memory function in animals and in normal volunteers. The present st udy reports the results of sabeluzole, in memory-impaired patients wit h localization-related (partial) epilepsy, A randomized, double-blind placebo-controlled parallel-group design was used. A total of 38 patie nts entered a prospective baseline, Five patients dropped out from the study, thus 33 patients were randomly assigned to either a 12-weeks t reatment with sabeluzole (n = 14) or placebo (n = 19). The treatment p hase was preceded by a titration phase of 4 weeks to obtain serum leve ls of sabeluzole between 50 and 130 ng/ml. In order to maintain blindn ess, a sham titration was carried out in the placebo group. The number of 'responders', i,e. patients with a >1 SD improvement on at least t hree of the memory tests was 9 out of 14 (64, 3 %) in the sabeluzole g roup and 7 out of 19 (36.8%) in the placebo group. This suggests a cli nically relevant effect of sabeluzole. The analysis of the memory test s showed a statistically significant improvement with sabeluzole on th e verbal long-term memory test, This could represent a specific drug e ffect and is in line with previous results of normal volunteer studies that also found improvement mainly restricted to the area of verbal l ong-term memory.