Registered on ClinicalTrials
N.A. SHAMALOV 1 , A.I. FEDIN 2 , G.S. RAKHIMBAYEVA 3 , E.S. NURGUZHAEV 4 , D.R. KHASANOVA 5 , E.Yu. SOLOVIOVA 2 , E.V. MELNIKOVA 6 , S.N. YANISHEVSKY 7 , V.V. MASHIN 8 , N.V. PIZOVA 9 , I.E. Poverennova 10 , S.E. CHUPRINA 11 , A.S. AGAFINA 12 , L.V. ROSHKOVSKA 13
1 Federal Center for Brain and Neurotechnology of the Federal Medical and Biological Agency of the Russian Federation, Moscow, Russia;
2 Pirogov Russian National Research Medical University, Moscow, Russia;
3 Tashkent Medical Academy, Tashkent, Uzbekistan;
4 Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan;
5 Kazan State Medical University, Kazan, Russia;
6 Leningrad Regional Center for Medical Rehabilitation, Kommunar, Russia;
7 Almazov National Medical Research Center, Saint Petersburg, Russia;
8 Ulyanovsk State University, Ulyanovsk, Russia;
9 Yaroslavl State Medical University, Yaroslavl, Russia.
10. Samara Regional Clinical Hospital named after V.D. Seredavin, Samara, Russia;
11. Voronezh Regional Clinical Hospital No. 1, Voronezh, Russia;
12. St. Petersburg City Hospital No. 40, St. Petersburg, Russia;
13. St. Petersburg Alexandrovskaya Hospital, St. Petersburg, Russia
Place of publication:
S.S. Korsakov Journal of Neurology and Psychiatry 2025, Vol. 125, No. 8, Issue 2, pp. 40–53
https://doi.org/10.17116/jnevro202512508240
Abstract
Objective of the study. To evaluate the comparative efficacy and safety of therapy with ethylmethylhydroxypyridine succinate (Mexidol, solution for intravenous and intramuscular administration, 50 mg/ml, and Mexidol FORTE 250, film-coated tablets, 250 mg) when used sequentially compared with placebo in patients in the acute and early recovery periods of ischemic stroke (IS).
Material and methods. A prospective, international, multicenter, randomized, double-blind, placebo-controlled study was conducted in parallel groups. The parameters of randomized patients in the acute and early recovery periods of ischemic stroke were measured at 4 visits. Patients were divided into 2 equal groups: the main group (standard therapy + Mexidol at a dose of 500 mg 2 times a day intravenously by drip in 100-200 ml of 0.9% NaCl solution for 10 days, then Mexidol FORTE 250 orally at a dose of 250 mg 3 times a day for 60 days) and placebo (standard therapy + placebo according to the same scheme as in the main group). The primary criterion for evaluating the effectiveness was the change in the results of assessing the patient's condition according to the modified Rankin Scale (mRS) at the end of therapy relative to the baseline level.
Results . A total of 304 patients were randomized to the study. The study groups were comparable by gender, age, and anthropometric parameters. Statistically significant differences were obtained, confirming the effectiveness of therapy with Mexidol. The Mexidol group showed a significant decrease in the degree of disability on the mRS scale, an improvement in neurological functions on the National Institutes of Health Stroke Scale (NIHSS), an increase in motor capabilities on the Rivermead Mobility Index, and a confident trend towards a decrease in cognitive deficit on the Montreal Cognitive Assessment (MoCA test). Statistically significant differences in favor of Mexidol when compared with placebo were noted for changes in the median score on the mRS scale at visit 4 relative to the baseline level (p = 0.003), changes in the median scores on the NIHSS scale (p < 0.001) and on the Rivermead index (p = 0.014). The use of Mexidol was associated with a decrease in the proportion of disabled patients (p=0.016) and an increase in the proportion of patients with an mRS score of 0–1 at visit 4 (p=0.002) compared with the placebo group. Adverse events (AEs) were identified in 35 (23%) patients in the Mexidol group (42 AEs in total) and in 35 (23%) in the placebo group (43 AEs in total) (p=1.000).
Conclusion. The study revealed statistically significant differences confirming the superior efficacy of Mexidol therapy compared to placebo in patients in the acute and early recovery periods of moderate ischemic stroke in terms of reducing the degree of disability, the severity of neurological deficits, enhancing motor function, and increasing mobility. Similar safety profiles were demonstrated for long-term sequential therapy with Mexidol and Mexidol FORTE 250 compared to placebo.
Key words : ischemic stroke, cerebral infarction, recovery after stroke, acute period of ischemic stroke, early recovery period of ischemic stroke, ethylmethylhydroxypyridine succinate, Mexidol, mRS, NIHSS, Rivermead Mobility Index, MoCA, safety.
Link to the study here
