Prospective International Multicenter Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety Evaluation of the Mexidol® Sequential Therapy of Patients in the Acute and Early Recovery Periods of Ischemic Stroke

MexidolMIR2023

Cerebral stroke is one of the most pressing clinical and social problems of modern medicine. According to WHO estimates, acute cerebral failure rank second among all causes of death. Optimizing the treatment of such conditions remains an urgent problem in neurology and rehabilitation.

2019-11-18

2023-08-18

2023-08-18

Completed

Early phase I

304

Inclusion Criteria: * Acute Ischemic Stroke confirmed by neuroimaging methods (CT, MRI) * Modified Rankin Scale, mRS ≥ 3 * National Institutes of Health Stroke Scale: 9 ≤ NIHSS ≤ 15 Exclusion Criteria: * Repeated or hemorrhagic stroke; * Traumatic brain injury with severe neurological symptoms and cognitive impairment; * Patients who have undergone thrombolytic therapy or thrombectomy; * History of clinically significant allergic reactions, hypersensitivity and/or intolerance to any component of the study drug or placebo; * Parkinson's disease, parkinsonism, multiple sclerosis, epilepsy, degenerative diseases of the central nervous system (CNS), history of dementia of the Alzheimer's type; * BMI (Body Mass Index) \> 35 * Systemic autoimmune diseases or vascular collagenoses requiring previous or current treatment with systemic corticosteroid drugs, cytostatics; * Malignant neoplasms within the last 5 years; * Need to use drugs prohibited in this study; * Having a positive result of a rapid test for IgM antibodies to the SARS-CoV-2 virus; * Need for surgical intervention; * History of alcohol or drug addiction; * Positive result of at least one of the following tests: blood test for HIV, syphilis, hepatitis B and C; * Pregnancy or lactation period; * Participation of the patient in any clinical trial less than 3 months before the start of the present one.

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2024-05-31