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

NCT06221826 | Completed Phase 4 Results

• 1 other identifier: MexidolNeuro2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Stroke, Acute

Keywords

Ischemic Stroke; Acute Stroke; Cerebral stroke; Traumatic Brain Injury; Acute Cerebrovascular Accident; ACVA; Acute cerebral failure; Neuroprotection; Mexidol; Ethylmethylhydroxypyridine Succinate

Outcome Measures

Primary Outcomes (10)

• Аssessment of Attentiveness and Performance

  Schulte test \[work efficiency\]. Test methodology: the subject is successively shown 5 tables (5x5), in the cells of which numbers (from 1 to 25) are randomly located. It is required to show and name all the numbers in ascending order (from 1 to 25). The time spent on each table separately is recorded. Depending on the objectives, the excess of the standard (40-50 sec) time spent on each table and the dynamics of time indicators, or the average or total result of the examination for all five tables, are analyzed \[test time: min value 30.0 sec, max value N/A; higher scores mean a worse outcome\].

  Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66).

• Dynamics of Cognitive Status

  The Montreal Cognitive Assessment (MoCA test) \[31 point scale: min value 0, max value 30, higher scores mean a better outcome\]

  Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66); Day 66 reported

• Severity of Depression

  The Beck Depression Inventory (BDI scale) \[64 point scale: min value 0, max value 63, higher scores mean a worse outcome\]

  Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported

• Reduction in Anxiety

  The Hospital Anxiety and Depression Scale (HADS) \[22 point scale: min value 0, max value 21, higher scores mean a worse outcome\]

  Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported

• Severity of Post Intensive Care Syndrome

  The Post Intensive Care Syndrome (PICS) score \[21 point scale: min value 0, max value 10 with 0,5 point scale division, higher scores mean a worse outcome\]

  Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported

• Dynamics of Level of Mobility

  The Rivermead index \[16 point scale: min value 0, max value 15, higher scores mean a better outcome\]

  Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported

• Dynamics of the Level of Life

  The Rehabilitation Routing Scale (RRS) \[7 point scale: min value 0, max value 6, higher scores mean a worse outcome\]

  Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported

• Severity and Dynamics of Muscle Strength

  The Muscle Strength Quantitative Rating (MRC) Scale \[6 point scale: min value 0, max value 5, higher scores mean a better outcome\]

  Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported

• Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points

  Systolic cerebral blood flow velocity (Vs) was measured in сm/sec using transcranial Doppler ultrasonography (TCD). Measurements were taken for each participant at five key time points: (1) before the first Mexidol infusion ("Before infusion"), (2) at the start of the infusion, (3) at the start of the Schulte test, (4) at the end of the Schulte test, and (5) at the end of the infusion. \[Normal values: min 35 сm/sec, max 95 сm/sec\]

  The TCDG parameters registrated before infusion, at the start of the infusion, at the start of the Schulte test, at the end of the Schulte test, at the end of the infusion.

• Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points

  The Overshoot Coefficient (OC) is a ratio reflecting the change in systolic cerebral blood flow velocity before and after specific stimuli. It was calculated based on transcranial Doppler measurements at five key time points: (1) before the first Mexidol infusion ("Before infusion"), (2) at the start of the infusion, (3) at the start of the Schulte test, (4) at the end of the Schulte test, and (5) at the end of the infusion. \[It's calculated by the formula OC=(Vo-Vs)/Vs, the norm is not less than 1.12\]

  The TCDG parameters registrated before infusion, at the start of the infusion, at the start of the Schulte test, at the end of the Schulte test, at the end of the infusion.

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Throughout the study [From Day 1 up to Day 66]

Study Arms (2)

Main (Mexidol and standard treatment)

EXPERIMENTAL

Mexidol IV 500 mg for 10 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks; and standard treatment

Drug: Mexidol

Control

NO INTERVENTION

Standard treatment: basic practices of kinesitherapy, occupational therapy, speech therapy, clinical psychology, supplemented by adjuvant procedures of electrotherapy and rehabilitation environment therapy. The patient's rehabilitation load was at least 3 hours a day for 12 days

Interventions

Mexidol DRUG

Neurocytoprotector

Also known as: Ethylmethylhydroxypyridine Succinate

Main (Mexidol and standard treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmasoft: lead

Study Sites (1)

Brain Institute Clinic

Yekaterinburg, Sverdlovsk Oblast, 623702, Russia

Location

Related Publications (1)

• Belkin AA, Belkin VA, Vasilchenko IE, Pinchuk EA. [Results of a cohort single-center randomized study of the modulating effect of the drug Mexidol in the rehabilitation of patients who suffered acute cerebral insufficiency]. Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(4):108-117. doi: 10.17116/jnevro2024124041108. Russian.

  PMID: 38676685 BACKGROUND

Related Links

• Belkin AA, Belkin VA, Vasilchenko IE, Pinchuk EA. \[Results of a cohort single-center randomized study of the modulating effect of the drug Mexidol in the rehabilitation of patients who suffered acute cerebral insufficiency\]

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Brain Injuries, Traumatic

Interventions

emoxypine succinate; ethylmethylhydroxypyridine succinate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Meshcherskiy Y.E., Medical director
• Organization: Pharmasoft

meshcherskiy_y@pharmasoft.ru

+7(495)626-47-55

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: April 17, 2023
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Locations

RU (1)