Safety and Efficacy of Sequential Therapy With Mexidol® in Patients With Chronic Cerebral Ischemia

NCT06834490 | Completed Phase 3 Results

• 2 other identifiers: MexidolMEMO2020PHS-CICADIS-005-MEX-SOL-TAB
• Study Type: interventional
• Target: 318
• Locations: 2 countries
• Sites: 14

Brief Summary

The purpose of this study is to evaluate safety and efficacy of sequential treatment with Mexidol® in patients with chronic cerebral ischemia (CCI).

Conditions

Chronic Cerebral Ischemia

Keywords

Chronic Cerebral Ischemia; CCI; Ischemia; Cerebral; Brain; Stroke; Cognitive; Neurobehavioral Manifestations; Neuroprotection; Mexidol; Ethylmethylhydroxypyridine Succinate; Cerebrovascular Disorders; Antioxidant Therapy; Stroke Recovery; Central Nervous System Disorders; Chronic Brain Hypoxia; Post-stroke Cognitive Impairment; Cognitive Impairment; Neurodegenerative; Neurodegenerative Processes; Neurological Rehabilitation; Oxidative Stress; Oxidative Stress Reduction; Energy Metabolism Enhancement; Central Nervous System; Cerebral Hypoxia

Outcome Measures

Primary Outcomes (1)

• Mean Score of Montreal Cognitive Assessment (MoCA) at Visit 5 in Comparison With Reference Score at Visit 0

  The Montreal Cognitive Assessment (MoCA) is used to measure the degree of cognitive impairment in patients with CCI. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. Higher score than shown at Visit 0 is expected after treatment.

  Day 75+2 (Visit 5) compared with the baseline level (Visit 0, 7 days before treatment)

Secondary Outcomes (9)

• Changes in the Severity of Cognitive Impairment Assessed With the Montreal Cognitive Assessment Scale Between Visit 0 and Visits 2 and 4

  Day 14 (Visit 2) and Day 44±2 (Visit 4) compared with the baseline level (Visit 0, 7 days before treatment)

• Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Physical Health)

  Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)

• Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Mental Health)

  Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)

• Changes in the Severity of Asthenia Assessed With the Multidimensional Fatigue Inventory (MFI-20)

  Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)

• Changes in the Anxiety Level According to the Beck Anxiety Inventory

  Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)

Study Arms (2)

Main (Mexidol)

ACTIVE COMPARATOR

Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days

Drug: Mexidol

Control (Placebo)

PLACEBO COMPARATOR

Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days

Drug: Placebo

Interventions

Mexidol DRUG

50 mg/ml IV solution, 250 mg tablets

Also known as: Ethylmethylhydroxypyridine Succinate

Main (Mexidol)

Placebo DRUG

Placebo IV solution, Placebo tablets

Control (Placebo)

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex aged from 40 to 90 years inclusive
• MoCA scale score of 25 and lower
• Patients meeting the criteria for the diagnosis: Mild (moderate) cognitive impairment when assessed by DSM-5.
• Chronic Cerebral Ischemia (ICD-10 code 167.8)
• Foci of leukoaraiosis or "silent" brain infarction documented by MRI/CT performed within the past 12 months.
• Patients who signed an informed consent to the study participation
• History of progressive multifocal or diffuse brain disease from 1 to 5 years
• Patients receiving background therapy with a fixed dose and combination of drugs during the previous month, including (if indicated): antiplatelet therapy, therapy of cerebral atherosclerosis and arterial hypertension, ischemic heart disease or other chronic diseases.
• Negative pregnancy test
• Patients who have agreed to use a reliable method of contraception during the study participation until completion (for women of childbearing potential, including partners of study participants).
• Patients who are able to understand all study requirements and who have consented to all the limitations imposed by the study

You may not qualify if:

• Investigator's or Sponsor's decision to exclude a participant from the study due to a clinically significant protocol deviation/violation.
• Serious adverse events or adverse events that do not meet the criteria for seriousness but may, in the investigator's opinion, be detrimental to the health or well-being of a participant if they continue participation in the study.
• Any adverse event (which may be unrelated to the investigational drug) requiring observations, procedures, and/or medications not approved by the clinical trial protocol.
• Participant's refusal to continue participation in the study or their lack of discipline
• Allergic reaction to the investigational drug that requires cancelling the treatment
• Participant's desire to terminate their participation early for any reason.
• Loss of contact with the patient followed by failure to attend the visit.
• The need to take therapies prohibited by this protocol: nootropic drugs, ethylmethylhydroxypyridine succinate, trimetazidine or meldonium, drugs affecting the function of the autonomic nervous system and other drugs that may, in the investigator's opinion, distort the study results.
• Pregnancy.

Sponsors & Collaborators

• Pharmasoft: lead

Study Sites (14)

Municipal Autonomous Healthcare Insitution of the Order of the Red Banner of Labour "City Clinical Hospital No.1"

Chelyabinsk, 454092, Russia

Location

Regional Budget Healthcare Institution "Ivanovo Regional Clinical Hospital"

Ivanovo, 152040, Russia

Location

Federal State Budget Educational Institution of Higher Education "Kazan State Medical University"

Kazan', 420012, Russia

Location

Federal State Budget Research Institution "Research Center of Neurology"

Moscow, 125367, Russia

Location

Federal State Budget Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education"

Moscow, 125445, Russia

Location

State Budget Healthcare Institution of the Novosibirsk Region "City Hospital № 34"

Novosibirsk, 630054, Russia

Location

Federal State Budget Research Institution "Federal Research Center for Fundamental and Translational Medicine"

Novosibirsk, 630117, Russia

Location

Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy n.a. S.M.Kirov"

Saint Petersburg, 194044, Russia

Location

City Hospital No.40 of the Kurortny District

Sestroretsk, 197706, Russia

Location

Private Healthcare Institution "Clinical Hospital "RR-Medicine" of Voronezh

Voronezh, 394024, Russia

Location

OOO "Centre for Evidence-Based Medicine"

Yaroslavl, 150000, Russia

Location

State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"

Yaroslavl, 150030, Russia

Location

State Budget Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"

Yekaterinburg, 620102, Russia

Location

Centre for Neurology and Neurorehabilitation n.a. N. M. Madzhido, OOO "Neyromed Servis"

Tashkent, 100187, Uzbekistan

Location

MeSH Terms

Conditions

Ischemia; Stroke; Neurobehavioral Manifestations; Cerebrovascular Disorders; Central Nervous System Diseases; Cognitive Dysfunction; Hypoxia, Brain

Interventions

emoxypine succinate; ethylmethylhydroxypyridine succinate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Hypoxia; Signs and Symptoms, Respiratory

Results Point of Contact

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

meshcherskiy_y@pharmasoft.ru

+ 7 (495) 626-47- 55

Study Officials

• Alina S. Agafina, MD, Cand.Med.Sci

  Saint Petersburg State Budget Healthcare Institution "City Hospital No.40 of the Kurortny District"

  PRINCIPAL INVESTIGATOR

• Elena V. Vostrikova, MD, Cand.Med.Sci

  State Budget Healthcare Institution of the Nivisibirsk Region "City Hospital No.34"

  PRINCIPAL INVESTIGATOR

• Andrey M. Alasheev, MD, Dr.Med.Sci

  State Budget Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"

  PRINCIPAL INVESTIGATOR

• Marine M. Tanashyan, Prof., Dr.Med.Sci

  Federal State Budget Research Institution "Research Center of Neurology"

  PRINCIPAL INVESTIGATOR

• Min G. Omelyanenko, MD, Dr.Med.Sci

  Regional Budget Healthcare Institution "Ivanovo Regional Clinical Hospital"

  PRINCIPAL INVESTIGATOR

• Stanislav O. Pozdnyakov, MD, Cand.Med.Sci

  OOO "Centre for Evidence-Based Medicine"

  PRINCIPAL INVESTIGATOR

• Aleksandr Y. Malygin, MD, Dr.Med.Sci

  State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"

  PRINCIPAL INVESTIGATOR

• Aida A. Yakupova, MD, Cand.Med.Sci

  Federal State Budget Educational Institution of Higher Education "Kazan State Meical University"

  PRINCIPAL INVESTIGATOR

• Igor V. Litvinenko, Prof., Dr.Med.Sci

  Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy n.a. S.M.Kirov"

  PRINCIPAL INVESTIGATOR

• Irina G. Lukashevich, MD

  Municipal Autonomous Healthcare Insitution of the Order of the Red Banner of Labour "City Clinical Hospital No.1"

  PRINCIPAL INVESTIGATOR

• Olga A. Sinitsyna, MD, Cand.Med.Sci

  State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"

  PRINCIPAL INVESTIGATOR

• Larisa A. Shchepankevich, MD, Dr.Med.Sci

  Federal State Budget Research Institution "Federal Research Center for Fundamental and Translational Medicine"

  PRINCIPAL INVESTIGATOR

• Galina A. Batishcheva, Prof., Dr.Med.Sci

  Private Healthcare Institution "Clinical Hospital "RR-Medicine" of Voronezh

  PRINCIPAL INVESTIGATOR

• Olga D. Ostroumova, Prof., Dr.Med.Sci

  Federal State Budget Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education"

  PRINCIPAL INVESTIGATOR

• Yokutkhon N. Madzhidova, Prof., Dr.Med.Sci

  Centre for Neurology and Neurorehabilitation n.a. N.M.Madzhido, OOO "Neyromed Servis"

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 19, 2025
• Study Start: November 5, 2019
• Primary Completion: December 8, 2020
• Study Completion: December 8, 2020
• Last Updated: October 6, 2025
• Results First Posted: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (13); UZ (1)