Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
304 participants
INTERVENTIONAL
2019-11-18
2023-08-18
Brief Summary
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Detailed Description
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As per protocol requirements, 313 participants were screened, 304 participants met all comprehensive eligibility criteria, 25 participants dropped out during the clinical trial period. The Modified Rankin Scale (mRS) was selected as the most representative primary outcome measuring tool due to the adequate representation of functional outcome. Additionally, the neuroprotective efficacy of Mexidol® was assessed for its ability to reduce stroke-related neurologic deficit, to improve mobility after stroke and to influence cognitive impairment and mood disorder symptoms.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mexidol®
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol (Ethylmethylhydroxypyridine Succinate)
50 mg/ml IV solution, 250 mg tablets
Placebo
Participants received Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo
Placebo IV solution, Placebo tablets
Interventions
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Mexidol (Ethylmethylhydroxypyridine Succinate)
50 mg/ml IV solution, 250 mg tablets
Placebo
Placebo IV solution, Placebo tablets
Eligibility Criteria
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Inclusion Criteria
* CT or MRI evidences of clinical diagnosis and no evidences of hemorrhagic stroke/hemorrhagic transformation of ischemic stroke.
* The written informed consent form (ICF) is signed and personally dated by the participant or by an impartial witness (by a person who is independent of the trial and cannot be unduly influenced by the people involved with the trial and who attends the informed consent process).
* The Modified Rankin Scale (mRS) score ≥3.
* The National Institutes of Health Stroke Scale (NIHSS) score from 9 to 15 points.
* Negative pregnancy test for women of childbearing age.
* Willingness to use reliable methods of contraception, and/or abstinence, for the duration of therapeutic product exposure.
* The ability to understand the purpose of research, risks associated with the research intervention, obligations and consequences of research participation and their right of withdrawing consent any time during the study.
Exclusion Criteria
* Recurrent or hemorrhagic stroke confirmed by CT/MRI.
* Hemorrhagic transformation of ischemic stroke.
* Parkinson's disease/parkinsonism.
* Progressive Multiple Sclerosis.
* Intractable Epilepsy.
* Demyelinating diseases of central nervous system.
* Hereditary and degenerative diseases of the central nervous system.
* Infectious diseases of central nervous system in medical history.
* Traumatic brain injury with severe neurocognitive impairment in medical history.
* Congenital malformations of the nervous system or any neurological disorders that can affect participant's capability (including cognitive and motor skills) to follow protocol procedures.
* Thrombolysis or thrombectomy treatment prior the enrollment.
* Medical history of severe allergies.
* Evidence of hypersensitivity reactions or intolerance associated with ethylmethylhydroxypyridine.
* Evidence of lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
* Acute surgical pathology.
* Evidence of clinically significant first identified disorder or disease that can affect participant's ability to participate in the clinical trial.
* Evidence of clinically significant severe disease/condition that can affect participant's ability to participate in the clinical trial: respiratory diseases, cardiovascular diseases (CVDs) including SAP ≥ 200 mm Hg and DAP ≥ 100 mm Hg, liver disease with elevation of ALT/AST \> 2 × ULN, kidney disease (еGFR\<30ml/min/1.73 m2), endocrine disorders and diseases, gastrointestinal diseases, pulmonary embolism (PE), deep vein thrombosis (DVT), floating thrombus, convulsive syndrome, uncontrolled hyperthermia, uncontrolled hyperglycemia.
* Medical history of severe mental disorder.
* Dementia of the Alzheimer type (DAT).
* Medical history of cancers within 5 years prior to enrollment.
* Medical history of alcohol/drug addiction.
* Pregnancy or breastfeeding.
* Prescription or use of prohibited medications within 2 weeks prior to enrollment.
* Positive HIV, syphilis, hepatitis B and C test.
* Positive COVID-19 test.
* Participation in another trial within 3 months prior to enrollment.
40 Years
75 Years
ALL
No
Sponsors
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Pharmasoft
INDUSTRY
Responsible Party
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Locations
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Almaty City Hospital № 7
Almaty, , Kazakhstan
Kazan City Hospital № 7
Kazan', , Russia
Kemerovo City Clinical Hospital № 11
Kemerovo, , Russia
Research Institute - Regional Clinical Hospital № 1
Krasnodar, , Russia
Federal Center for Brain and Neurotechnology
Moscow, , Russia
Russian National Research Medical University n.a. N. I. Pirogov
Moscow, , Russia
Rostov State Medical University
Rostov-on-Don, , Russia
Alexandrovskaya Hospital
Saint Petersburg, , Russia
St. Petersburg Clinical Hospital № 26
Saint Petersburg, , Russia
City Hospital № 40 of Kurortny District
Saint Petersburg, , Russia
Samara Regional Clinical Hospital n.a. V. D. Seredavin
Samara, , Russia
Central Clinical Medical and Sanitary Unit n.a. V. A. Egorov
Ulyanovsk, , Russia
Voronezh Regional Clinical Hospital № 1
Voronezh, , Russia
Vsevolozhsk Clinical Interdistrict Hospital
Vsevolozhsk, , Russia
Yaroslavl Clinical Hospital № 2 (ICU)
Yaroslavl, , Russia
Yaroslavl Clinical Hospital № 2
Yaroslavl, , Russia
The first clinic of the Tashkent Medical Academy
Tashkent, , Uzbekistan
Countries
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References
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Shamalov NA, Fedin AI, Rakhimbaeva GS, Nurguzhaev ES, Khasanova DR, Solovyova EY, Melnikova EV, Yanishevsky SN, Mashin VV, Pizova NV, Poverennova IE, Chuprina SE, Agafina AS, Roshkovskaya LV. [Results of the international multicenter randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of the sequential therapy with ethylmethylhydroxypyridine succinate in patients in the acute and early recovery periods of ischemic stroke (MIR)]. Zh Nevrol Psikhiatr Im S S Korsakova. 2025;125(8. Vyp. 2):40-53. doi: 10.17116/jnevro202512508240. Russian.
Koltsov IA, Shchukin IA, Fidler MS, Glukhareva AP, Chubykin VI. [Multimodal antioxidant therapy in ischemic stroke: from MIR trial to bedside]. Zh Nevrol Psikhiatr Im S S Korsakova. 2025;125(12. Vyp. 2):64-71. doi: 10.17116/jnevro202512512264. Russian.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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PHS-APIS-004-MEX-SOL-TAB
Identifier Type: OTHER
Identifier Source: secondary_id
MexidolMIR2023
Identifier Type: -
Identifier Source: org_study_id