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Stroke recovery drug shows promise in major trial

NCT ID NCT06437626

Disease control Sponsor: Pharmasoft Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding Mexidol to standard stroke care helps people recover better after a first ischemic stroke. 304 adults who had a stroke within 48 hours were given either Mexidol or a placebo for about 10 weeks. Researchers measured disability, neurological symptoms, and mobility to see if Mexidol improves recovery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

304 people

The number who actually took part.

Started

Nov 2019

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

brain ischemia ischemic stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke

Contacts and locations

Locations

  • Alexandrovskaya Hospital

    Saint Petersburg, 193312, Russia

  • Almaty City Hospital № 7

    Almaty, 050006, Kazakhstan

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

    Ulyanovsk, 432026, Russia

  • City Hospital № 40 of Kurortny District

    Saint Petersburg, 197706, Russia

  • Federal Center for Brain and Neurotechnology

    Moscow, 117997, Russia

  • Kazan City Hospital № 7

    Kazan', 420103, Russia

  • Kemerovo City Clinical Hospital № 11

    Kemerovo, 650014, Russia

  • Research Institute - Regional Clinical Hospital № 1

    Krasnodar, 350086, Russia

  • Rostov State Medical University

    Rostov-on-Don, 344022, Russia

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

    Moscow, 117997, Russia

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

    Samara, 443095, Russia

  • St. Petersburg Clinical Hospital № 26

    Saint Petersburg, 196247, Russia

  • The first clinic of the Tashkent Medical Academy

    Tashkent, 100109, Uzbekistan

  • Voronezh Regional Clinical Hospital № 1

    Voronezh, 394066, Russia

  • Vsevolozhsk Clinical Interdistrict Hospital

    Vsevolozhsk, 188643, Russia

  • Yaroslavl Clinical Hospital № 2

    Yaroslavl, 150030, Russia

  • Yaroslavl Clinical Hospital № 2 (ICU)

    Yaroslavl, 150030, Russia

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