STUDIO MULTICENTRICO CON VIGABATRIN NELL'EPILESSIA FARMACORESISTENTE

The aim of this study was to assess clinical response to vigabatrin as add-on therapy in drug-resistant epileptic patients, experiencing at least four seizures a month and receiving no more than two other anticonvulsants. The study, multicenter (twelve centers), single-blind and placebo-controlled in design, was carried out in four consecutive eight-week phases: observation period (baseline), followed by placebo addition to the existing therapy, subsequent cross-over to vigabatrin 2 g/day fixed dose' and dose titration to optimize individual response. At the end of this period, only patients showing a good response to VGB entered a long-term maintenance phase. So far, 94 patients entered the active treatment phase, most of them suffering from complex partial seizures. As compared to the placebo period, administration of VGB was associated with a significant reduction in fit frequency (p<0.001), a greater than 50% reduction in seizure number being observed in 44 cases. Drowsiness and body weight gain were the most frequently reported side effects.