Efficacy and Safety of Mexidol® in Stroke Therapy

NCT06437626 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2025-12-30

Study results available
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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

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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Entities

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 NCT06437626 on ClinicalTrials.gov