Efficacy and Safety of Mexidol® in Stroke Therapy

NCT06437626 | Completed Phase 3 Results

• 2 other identifiers: MexidolMIR2023PHS-APIS-004-MEX-SOL-TAB
• Study Type: interventional
• Target: 304
• Locations: 3 countries
• Sites: 17

Brief Summary

The main purpose of the clinical trial is to evaluate the efficacy and safety of Mexidol® in sequential treatment for patients in the acute and early recovery periods of ischemic stroke compared to placebo. The effect of adding Mexidol® to standard therapy on the degree of impairment of vital functions was assessed including the degree of disability (according to the Modified Rankin Scale, mRS), the severity of neurological symptoms (according to the National Institutes of Health Stroke Scale, NIHSS) and the level of mobility of patients (according to the Rivermead Mobility Index).

Conditions

Ischemic Stroke

Keywords

Stroke; Ischemic Stroke; Neuroprotective Agents; Antioxidants; Stroke Rehabilitation; Recovery of Function; Brain Ischemia; Acute Stroke; Acute Cerebrovascular Accident; Cerebral Stroke; Neuroprotection; Mexidol; Ethylmethylhydroxypyridine Succinate

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Modified Rankin Scale (mRS) Scores at the End of the Course of Therapy

  The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 5 (dead) \[6 point scale: min value 0, max value 5, higher scores mean a worse outcome\]. Change = (Visit 4, Day 71(+2) - Visit 0, Day 0-1 Scores).

  Baseline, Day 71

Secondary Outcomes (7)

• Percentage of Subjects Having Modified Rankin Scale (mRS) Scores >3 (Higher Degree of Disability) at the End of the Course of Therapy

  Day 71

• Percentage of Subjects Having Modified Rankin Scale (mRS) Scores 0-1 (Normal or Lower Degree of Disability) at the End of the Course of Therapy

  Day 71

• Change From Baseline in the National Institutes of Health Stroke Scale (NIHSS) Score at the End of the Course of Therapy

  Baseline, Day 71

• Change From Baseline in the Rivermead Mobility Index (RMI) Score at the End of the Course of Therapy

  Baseline, Day 71

• Change From Baseline in the Montreal Cognitive Assessment (MoCA) Score at the End of the Course of Therapy

  Baseline, Day 71

Study Arms (2)

Mexidol®

EXPERIMENTAL

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

Drug: Mexidol (Ethylmethylhydroxypyridine Succinate)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Mexidol (Ethylmethylhydroxypyridine Succinate) DRUG

50 mg/ml IV solution, 250 mg tablets

Mexidol®

Placebo DRUG

Placebo IV solution, Placebo tablets

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of first-ever hemispheric ischemic stroke (codes ICD-10: I63.0 - I63.9) with the time from onset of a stroke \<48 hours.
• 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.

You may not qualify if:

• BMI (Body Mass Index) \> 35.
• 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.

Sponsors & Collaborators

• Pharmasoft: lead

Study Sites (17)

Almaty City Hospital № 7

Almaty, 050006, Kazakhstan

Location

Kazan City Hospital № 7

Kazan', 420103, Russia

Location

Kemerovo City Clinical Hospital № 11

Kemerovo, 650014, Russia

Location

Research Institute - Regional Clinical Hospital № 1

Krasnodar, 350086, Russia

Location

Federal Center for Brain and Neurotechnology

Moscow, 117997, Russia

Location

Russian National Research Medical University n.a. N. I. Pirogov

Moscow, 117997, Russia

Location

Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

Alexandrovskaya Hospital

Saint Petersburg, 193312, Russia

Location

St. Petersburg Clinical Hospital № 26

Saint Petersburg, 196247, Russia

Location

City Hospital № 40 of Kurortny District

Saint Petersburg, 197706, Russia

Location

Samara Regional Clinical Hospital n.a. V. D. Seredavin

Samara, 443095, Russia

Location

Central Clinical Medical and Sanitary Unit n.a. V. A. Egorov

Ulyanovsk, 432026, Russia

Location

Voronezh Regional Clinical Hospital № 1

Voronezh, 394066, Russia

Location

Vsevolozhsk Clinical Interdistrict Hospital

Vsevolozhsk, 188643, Russia

Location

Yaroslavl Clinical Hospital № 2 (ICU)

Yaroslavl, 150030, Russia

Location

Yaroslavl Clinical Hospital № 2

Yaroslavl, 150030, Russia

Location

The first clinic of the Tashkent Medical Academy

Tashkent, 100109, Uzbekistan

Location

Related Publications (2)

• 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.

  PMID: 40898634 BACKGROUND

• 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.

  PMID: 41456191 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Brain Ischemia

Interventions

emoxypine succinate; ethylmethylhydroxypyridine succinate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Meshcherskiy Y.E., Medical director
• Organization: Pharmasoft

pharmasoft@pharmasoft.ru

+ 7 (495) 626-47-55

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: November 18, 2019
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: December 30, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-12

Locations

KA (1); RU (15); UZ (1)