Efficacy and Safety of Mexidol® in Stroke Therapy

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 hemorrhagicstroke/hemorrhagic transformation of ischemic stroke.

• The written informed consent form (ICF) is signed and personally dated by theparticipant or by an impartial witness (by a person who is independent of the trialand cannot be unduly influenced by the people involved with the trial and whoattends 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 theduration of therapeutic product exposure.

• The ability to understand the purpose of research, risks associated with theresearch intervention, obligations and consequences of research participation andtheir 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 thatcan affect participant's capability (including cognitive and motor skills) to followprotocol procedures.

• Thrombolysis or thrombectomy treatment prior the enrollment.

• Medical history of severe allergies.

• Evidence of hypersensitivity reactions or intolerance associated withethylmethylhydroxypyridine.

• Evidence of lactose intolerance, galactose intolerance, Lapp lactase deficiency orglucose-galactose malabsorption.

• Acute surgical pathology.

• Evidence of clinically significant first identified disorder or disease that canaffect participant's ability to participate in the clinical trial.

• Evidence of clinically significant severe disease/condition that can affectparticipant's ability to participate in the clinical trial: respiratory diseases,cardiovascular diseases (CVDs) including SAP ≥ 200 mm Hg and DAP ≥ 100 mm Hg, liverdisease 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.