RecruitingPhase 4NCT07575984

Mexidol® Safety and Efficacy in Treatment of Hyperacute and Acute Ischemic Stroke

A Pilot, Randomized, Multicenter, Comparative, Open-label Study to Evaluate the Clinical, Laboratory, and Instrumental Efficacy and Safety of Mexidol® Solution for Intravenous and Intramuscular Administration, 50 mg/mL (LLC RPC "PHARMASOFT", Russia), and Mexidol® FORTE 250 Film-coated Tablets, 250 mg (LLC RPC "PHARMASOFT", Russia), in the Treatment of Ischemic Stroke in Hyperacute and Acute Periods

Sponsor

Pharmasoft

Enrollment

120 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Ischemic Stroke

Summary

The primary objective of this study is to further define the mechanisms of action of Mexidol® (solution for intravenous and intramuscular injection, 50 mg/ml) and Mexidol® FORTE 250 (film-coated tablets, 250 mg) in the hyperacute and acute periods of ischemic stroke, and to evaluate their impact on clinical and neuroimaging outcomes of the disease.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Glycine and a drug called Mexidol for people with ischemic stroke. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMexidol

Phase 1 (Days 1-10): Mexidol® solution, 500 mg (10 ml) twice daily (total daily dose 1000 mg) administered via IV infusion in 100-200 ml of 0.9% NaCl solution for 10 days. Infusion rate: 40-60 drops per minute. Phase 2 (Days 11-70): Mexidol® FORTE 250 film-coated tablets, 250 mg three times daily (total daily dose 750 mg) for 60 days. Administered on top of standard background therapy in accordance with the 2024 Clinical Guidelines of the Ministry of Health of the Russian Federation for Ischemic Stroke and TIA.

DRUGGlycine

Glycine, 100 mg sublingual tablets, 1 g (10 tablets) daily for 5 days. Administered on top of standard background therapy in accordance with the 2024 Clinical Guidelines of the Ministry of Health of the Russian Federation for Ischemic Stroke and TIA.