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Current requirements for studies of drugs for the pathogenetic treatment of multiple sclerosis

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More than 10 multiple sclerosis-modifying drugs (MSMDs) are widely used now. Novel MSMDs should be investigated in strict accordance with the evidence-based medicine principles governing clinical trials (of both original drugs and their analogues) that prove the high efficiency, safety, and tolerability of new drugs versus the already existing ones. Russia has gained extensive experience in conducting such studies using the well-known drugs as a comparison group. The efficiency and safety of new therapy should be evaluated according to the international criteria on the basis of a sufficient number of patients during a long-term follow-up. When combining the drugs, their efficiency and the risk of adverse effects can vary. The published results of a small study of the combined drug Leucovir (Belarus) do not meet these requirements, and the possibility of using this drug to treat multiple sclerosis can be discussed only after adequate phases II and III clinical trials.

About the Authors

A. N. Boyko
Department of Neurology, Neurosurgery, and Medical Genetics, N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia; Department of Neuroimmunology, Federal Center for Cerebrovascular Pathology and Stroke, Ministry of Health of Russia
Russian Federation

1, Ostrovityanov St, Moscow 117997;

1, Ostrovityanov St., Build. 10, Moscow 117997

N. N. Spirin
Department of Neurology, Neurosurgery, and Medical Genetics, Yaroslavl State Medical University, Ministry of Health of Russia
Russian Federation
5, Revolutsionnaya St., Yaroslavl 150000

Ya. V. Vlasov
Department of Neurology and Neurosurgery, Samara State Medical University, Ministry of Health of Russia
Russian Federation
89, Chapaevskaya St., Samara 443099

M. N. Zakharova
Research Center of Neurology, Ministry of Education and Science of Russia
Russian Federation
80, Volokolamskoe Shosse, Moscow 125367


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For citations:

Boyko A.N., Spirin N.N., Vlasov Y.V., Zakharova M.N. Current requirements for studies of drugs for the pathogenetic treatment of multiple sclerosis. Neurology, Neuropsychiatry, Psychosomatics. 2019;11(4):166-171. (In Russ.)

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ISSN 2074-2711 (Print)
ISSN 2310-1342 (Online)