Efficacy and Safety of Mexidol® in Stroke Therapy
NCT06437626 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304
Last updated 2025-12-30
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).
Conditions
Interventions
- DRUG
-
Mexidol (Ethylmethylhydroxypyridine Succinate)
50 mg/ml IV solution, 250 mg tablets
- DRUG
-
Placebo IV solution, Placebo tablets
Sponsors & Collaborators
-
Pharmasoft
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-18
- Primary Completion
- 2023-08-18
- Completion
- 2023-08-18
Countries
- Kazakhstan
- Russia
- Uzbekistan
Study Locations
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