Ischemic StrokePhase 3MIRNCT06437626
Efficacy and Safety of Mexidol® in Stroke Therapy
A Phase 3 study testing Mexidol (Ethylmethylhydroxypyridine Succinate) in people with Ischemic Stroke, run by Pharmasoft at 17 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Mexidol (Ethylmethylhydroxypyridine Succinate)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 18 Nov 2019to 18 Aug 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
Russia15 sites
Kazan City Hospital № 7
Kazan', 420103
Kemerovo City Clinical Hospital № 11
Kemerovo, 650014
Research Institute - Regional Clinical Hospital № 1
Krasnodar, 350086
Federal Center for Brain and Neurotechnology
Moscow, 117997
Russian National Research Medical University n.a. N. I. Pirogov
Moscow, 117997
Rostov State Medical University
Rostov-on-Don, 344022
Alexandrovskaya Hospital
Saint Petersburg, 193312
St. Petersburg Clinical Hospital № 26
Saint Petersburg, 196247
City Hospital № 40 of Kurortny District
Saint Petersburg, 197706
Samara Regional Clinical Hospital n.a. V. D. Seredavin
Samara, 443095
Central Clinical Medical and Sanitary Unit n.a. V. A. Egorov
Ulyanovsk, 432026
Voronezh Regional Clinical Hospital № 1
Voronezh, 394066
Vsevolozhsk Clinical Interdistrict Hospital
Vsevolozhsk, 188643
Yaroslavl Clinical Hospital № 2 (ICU)
Yaroslavl, 150030
Yaroslavl Clinical Hospital № 2
Yaroslavl, 150030
Uzbekistan1 site
The first clinic of the Tashkent Medical Academy
Tashkent, 100109
About this study
Official title: Prospective International Multicenter Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Mexidol® in Sequential Treatment of Patients in the Acute and Early Recovery Periods of Ischemic Stroke
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).
Read the detailed description
As the main purpose of the clinical study is to evaluate safety and efficacy of a neuroprotector (Mexidol®), it was crucial to develop strict protocol requirements that would help to avoid the challenges of estimation of neuroprotective effect for stroke therapy. The current treatment options for stroke are still limited and do not take into account rehabilitation period and patients' further quality of life.
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
- Ischemic Stroke
- Being tested
- Mexidol (Ethylmethylhydroxypyridine Succinate), Placebo
- 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
- Medical subject headings
- Ischemic Stroke, Stroke, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mexidol (Ethylmethylhydroxypyridine Succinate)Drug
50 mg/ml IV solution, 250 mg tablets
PlaceboDrug
Placebo IV solution, Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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].
Measured: 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
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].
Measured: Day 71
Change From Baseline in the National Institutes of Health Stroke Scale (NIHSS) Score at the End of the Course of Therapy
The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42 (severe stroke), with the minimum score being a 0 (no stroke symptoms) [43 point scale: min value 0, max value 42, higher scores mean a worse outcome]. Change = (Visit 4, Day 71(+2) - Visit 0, Day 0-1 Scores).
Measured: Baseline, Day 71
Change From Baseline in the Rivermead Mobility Index (RMI) Score at the End of the Course of Therapy
The Rivermead Mobility Index (RMI) is a hierarchical mobility scale used in neurological rehabilitation. It includes 15 items related to bed mobility, transfers, walking, stair use, and running. The test is comprised of 14 questions, and the patient is then asked to stand for 10 seconds without any aid. Each response is scored yes or no with 1 point for each yes answer. The scores are summed with a range from 0 (poor mobility) to 15 (excellent mobility) [16 point scale: min value 0, max value 15, higher scores mean a better outcome]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores).
Measured: Baseline, Day 71
Change From Baseline in the Montreal Cognitive Assessment (MoCA) Score at the End of the Course of Therapy
The Montreal Cognitive Assessment (MoCA) is a 30-point validated scale that covers multiple cognitive domains including spatiotemporal orientation, sustained attention, visuospatial function, executive function, verbal memory, language, naming, and abstract thinking [31 point scale: min value 0, max value 30, higher scores mean a better outcome]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores).
Measured: Baseline, Day 71
Change From Baseline in the Hospital Anxiety and Depression Scale Score, Domain ANXIETY (HADS-A), at the End of the Course of Therapy
The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure that was specifically designed to screen for distinct dimensions of anxiety and depression in nonpsychiatric hospital departments; somatic symptoms were excluded [22 point scale for each domain (Anxiety or Depression): min value 0, max value 21, higher scores mean a worse outcome]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores).
Measured: Baseline, Day 71
Change From Baseline in the Hospital Anxiety and Depression Scale Score, Domain DEPRESSION (HADS-D), at the End of the Course of Therapy
The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure that was specifically designed to screen for distinct dimensions of anxiety and depression in nonpsychiatric hospital departments; somatic symptoms were excluded [22 point scale for each domain (Anxiety or Depression): min value 0, max value 21, higher scores mean a worse outcome]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores).
Measured: Baseline, Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start18 Nov 2019
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmasoft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437626
- Sponsor's protocol ID
- MexidolMIR2023
- Other IDs
- PHS-APIS-004-MEX-SOL-TAB
- Acronym
- MIR
- Status last verified
- Dec 2025
- First submitted
- 24 May 2024
- Last updated
- 30 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40898634Koltsov 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.
PubMed 41456191