Phase 3
N=304
Efficacy and Safety of Mexidol® in Stroke Therapy
Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT06437626 ↗Enrolled (actual)
304
Serious AEs
3.3%
Results posted
Dec 2025
Primary outcome: Primary: Change From Baseline in the Modified Rankin Scale (mRS) Scores at the End of the Course of Therapy — -2.45; -2.01 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mexidol (Ethylmethylhydroxypyridine Succinate) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Pharmasoft
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Modified Rankin Scale (mRS) Scores at the End of the Course of Therapy |
-2.45; -2.01 | — |
| SECONDARY Percentage of Subjects Having Modified Rankin Scale (mRS) Scores >3 (Higher Degree of Disability) at the End of the Course of Therapy |
22; 39 | — |
| SECONDARY 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 |
85; 57 | — |
| SECONDARY Change From Baseline in the National Institutes of Health Stroke Scale (NIHSS) Score at the End of the Course of Therapy |
-7; -7 | — |
| SECONDARY Change From Baseline in the Rivermead Mobility Index (RMI) Score at the End of the Course of Therapy |
10; 9 | — |
| SECONDARY Change From Baseline in the Montreal Cognitive Assessment (MoCA) Score at the End of the Course of Therapy |
4; 3 | — |
| SECONDARY Change From Baseline in the Hospital Anxiety and Depression Scale Score, Domain ANXIETY (HADS-A), at the End of the Course of Therapy |
-2; -1 | — |
| SECONDARY Change From Baseline in the Hospital Anxiety and Depression Scale Score, Domain DEPRESSION (HADS-D), at the End of the Course of Therapy |
-2; -1 | — |
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).
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT06437626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.