The study was taken up to compare the effect of treatment with ganglioside GM1 (Sygen, FIDIA-Italy) and typical treatment in the course of the disease. The study included 98 patients aged 40-82 in good or moderately good physical condition, with the ischaemic stroke confirmed by CT scan, in early stage of stroke (within 48 hours after onset). Patients with severe physical diseases were excluded. The patients were divided at random into two groups. Group I (50 patients) was treated typically and group II (48 patients) was given both typical treatment and ganglioside GM1 administered in 100 mg daily doses over 30 days, i.v. during first 5 days, then i.m. The neurological state was assessed according to the Canadian Neurological Scale (CNS), general fitness according to the Ranking Classification of Neurologic Disability Status (RS) at the admission and after 30 days of the treatment. After 30 days of the treatment no difference between the two groups was found in: 1) mortality, 2) mean survival time, 3) neurological state, 4) patient general fitness. According to the above results the beneficial influence of Sygen treatment of ischaemic stroke was not confirmed.