Efficacy and safety of treatment with ampasse: the results of a randomized, double-blind, placebo-controlled trial in patients with chronic cerebrovascular disorders

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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.

Keywords:

neuroprotective therapy

chronic cerebrovascular disorder

cognitive functions

quality of life

safety

Authors:

Skoromets A.A.

Pavlov First Saint Petersburg State Medical University

ORCID: 0000-0002-5884-3110

Kotov S.V.

Vladimirsky Moscow Regional Research Clinical Institute

SPIN RSCI: 1798-0837
Scopus AuthorID: 7005990035
ResearcherID: E-4451-2017
ORCID: 0000-0002-8706-7317

Voronkov P.B.

Multidisciplinary Medical Center LLC «OrKli»

Popova V.V.

Saint Petersburg State Paediatric Medical University

Zubkova T.G.

Smorodintsev Research Institute of Influenza

Kiselev A.V.

Semenov Institute of Chemical Physics

Received:

19.03.2021

Accepted:

27.04.2021

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