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

NCT07575984 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Mexidol

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.

DRUG

Glycine

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.

Sponsors & Collaborators

  • Pharmasoft

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-04
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07575984 on ClinicalTrials.gov