Phase 4 N=60 Randomized Treatment

MEXIDOL® in the Rehabilitation Treatment of Patients With Acute Cerebral Failure

Ischemic Stroke, Acute

Bottom Line

View on ClinicalTrials.gov: NCT06221826 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Аssessment of Attentiveness and Performance — 94.9; 71.2; 75; 68.15 seconds

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Mexidol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pharmasoft
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Аssessment of Attentiveness and Performance	94.9; 71.2; 75; 68.15; 71.7; 63	—
PRIMARY Dynamics of Cognitive Status	23.8; 22.9	—
PRIMARY Severity of Depression	7.5; 11.4	—
PRIMARY Reduction in Anxiety	2.6; 4.4	—
PRIMARY Severity of Post Intensive Care Syndrome	0.02; 0.3	—
PRIMARY Dynamics of Level of Mobility	10.3; 8.0	—
PRIMARY Dynamics of the Level of Life	2.9; 3.3	—
PRIMARY Severity and Dynamics of Muscle Strength	3.3; 2.1	—
PRIMARY Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points	72.6; 80.03; 72.23; 80.8; 74.6; 83.57	—
PRIMARY Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points	1.25; 1.27; 1.26; 1.27; 1.25; 1.27	—
SECONDARY Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	0; 0	—

Summary

The use of metabolic modulators creates prospects for increasing the efficiency of the rehabilitation treatment of patients with acute cerebral failure

Eligibility Criteria

Inclusion Criteria

Acute Ischemic Stroke
Montreal Cognitive Assessment (MoCA) test >15; ≤22

Exclusion Criteria

Under 18 years old
Epilepsy
Pregnancy
Acute failure of one or more organ systems
Purulent-inflammatory disease of any localization
Participating in any other clinical trial

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06221826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.