[Efficacy and safety of treatment with ampasse: the results of a randomized, double-blind, placebo-controlled trial in patients with chronic cerebrovascular disorders]. / Effektivnost' i bezopasnost' terapii preparatom ampasse: rezul'taty randomizirovannogo dvoinogo slepogo platsebo-kontroliruemogo issledovaniya u patsientov s khronicheskim narusheniem mozgovogo krovoobrashcheniya.

ABSTRACT

OBJECTIVE: To assess the efficacy and safety of the drug ampasse in the treatment of patients with chronic cerebrovascular disorders (CCVD). MATERIALS AND METHODS: A multicenter, randomized, double-blind, placebo-controlled, confirmatory study of the efficacy and safety of ampasse (phase III) was conducted in 124 patients aged 50 to 75 years. The main group (MG) - 62 patients, received the test drug ampasse, solution for intravenous administration, 5 mg/ml, at a dose of 5 ml (25 mg), intravenously bolus slowly, the duration of treatment was 15 days. Control group (CG) - 62 patients, received comparison drug placebo (0.9% sodium chloride-5 ml). RESULTS: All 124 patients fully completed the procedures and visits, there were no dropouts from the study. The proportion of patients who reached the primary endpoint (an increase in the score by 2 or more points on the MoCA scale) was 83.87% in MG and 22.58% in CG, that is, the efficacy of therapy in MG was 61.29% higher than in CG (p<0.001), and good tolerability of the drug was proved. The secondary endpoint is an increase in quality of life (QOL) on the SF-36 V2 scale on Day 31. In MG, there was a statistically significant improvement in all indicators of QOL compared to the baseline. When assessing the safety spectrum, the proportion of patients who had adverse events was 14.52% in MG and 8.06% in CG (p=0.395). CONCLUSION: Ampasse has a positive effect on cognitive functions and QOL, does not increase the frequency of adverse events in patients with CCVD compared to placebo, does not cause significant side effects, and is well tolerated by patients.