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

NCT ID: NCT06834490

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2020-12-08

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).

Detailed Description

Chronic cerebral ischemia (CCI) is a cerebral vascular pathology caused by slow progressive diffuse disruption of blood flow to the brain with gradually increasing defects in its functioning. The activation of lipid peroxidation with the release of large amounts of active oxygen radicals plays the key role in the pathogenesis of ischemic disorders, which leads to the development of oxidative stress. However, traditional drug therapy, which is aimed at improving blood flow to the brain, is mainly based on drugs with psychostimulant component, and does not always prevent the increase of oxidative damage to the patients' body. That is why it is necessary to search for drugs that would correct these processes selectively. Mexidol contains ethylmethylhydroxypyridine succinate as an active substance and may be the drug of choice for the treatment of CCI patients.

Conditions

Chronic Cerebral Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Main (Mexidol)

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

Group Type: ACTIVE_COMPARATOR

Mexidol

Intervention Type: DRUG

50 mg/ml IV solution, 250 mg tablets

Control (Placebo)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo IV solution, Placebo tablets

Interventions

Mexidol

50 mg/ml IV solution, 250 mg tablets

Intervention Type: DRUG

Placebo

Placebo IV solution, Placebo tablets

Intervention Type: DRUG

Other Intervention Names

Ethylmethylhydroxypyridine Succinate

Eligibility Criteria

Inclusion Criteria

1. Patients of either sex aged from 40 to 90 years inclusive

2. MoCA scale score of 25 and lower

3. Patients meeting the criteria for the diagnosis: Mild (moderate) cognitive impairment when assessed by DSM-5.

4. Chronic Cerebral Ischemia (ICD-10 code 167.8)

5. Foci of leukoaraiosis or "silent" brain infarction documented by MRI/CT performed within the past 12 months.

6. Patients who signed an informed consent to the study participation

7. History of progressive multifocal or diffuse brain disease from 1 to 5 years

8. 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.

9. Negative pregnancy test

10. 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).

11. Patients who are able to understand all study requirements and who have consented to all the limitations imposed by the study

2. Investigator's or Sponsor's decision to exclude a participant from the study due to a clinically significant protocol deviation/violation.

3. 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.

4. Any adverse event (which may be unrelated to the investigational drug) requiring observations, procedures, and/or medications not approved by the clinical trial protocol.

5. Participant's refusal to continue participation in the study or their lack of discipline

6. Allergic reaction to the investigational drug that requires cancelling the treatment

7. Participant's desire to terminate their participation early for any reason.

8. Loss of contact with the patient followed by failure to attend the visit.

9. 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.

10. Pregnancy.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmasoft

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alina S. Agafina, MD, Cand.Med.Sci

Role: PRINCIPAL_INVESTIGATOR

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

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

Role: PRINCIPAL_INVESTIGATOR

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

Andrey M. Alasheev, MD, Dr.Med.Sci

Role: PRINCIPAL_INVESTIGATOR

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

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

Role: PRINCIPAL_INVESTIGATOR

Federal State Budget Research Institution "Research Center of Neurology"

Min G. Omelyanenko, MD, Dr.Med.Sci

Role: PRINCIPAL_INVESTIGATOR

Regional Budget Healthcare Institution "Ivanovo Regional Clinical Hospital"

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

Role: PRINCIPAL_INVESTIGATOR

OOO "Centre for Evidence-Based Medicine"

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

Role: PRINCIPAL_INVESTIGATOR

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

Aida A. Yakupova, MD, Cand.Med.Sci

Role: PRINCIPAL_INVESTIGATOR

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

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

Role: PRINCIPAL_INVESTIGATOR

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

Irina G. Lukashevich, MD

Role: PRINCIPAL_INVESTIGATOR

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

Olga A. Sinitsyna, MD, Cand.Med.Sci

Role: PRINCIPAL_INVESTIGATOR

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

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

Role: PRINCIPAL_INVESTIGATOR

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

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

Role: PRINCIPAL_INVESTIGATOR

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

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

Role: PRINCIPAL_INVESTIGATOR

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

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

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Chelyabinsk, , Russia

Regional Budget Healthcare Institution "Ivanovo Regional Clinical Hospital"

Ivanovo, , Russia

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

Kazan', , Russia

Federal State Budget Research Institution "Research Center of Neurology"

Moscow, , Russia

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

Moscow, , Russia

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

Novosibirsk, , Russia

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

Novosibirsk, , Russia

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

Saint Petersburg, , Russia

City Hospital No.40 of the Kurortny District

Sestroretsk, , Russia

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

Voronezh, , Russia

OOO "Centre for Evidence-Based Medicine"

Yaroslavl, , Russia

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

Yaroslavl, , Russia

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

Yekaterinburg, , Russia

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

Tashkent, , Uzbekistan

Countries

Russia; Uzbekistan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PHS-CICADIS-005-MEX-SOL-TAB

Identifier Type: OTHER

Identifier Source: secondary_id

MexidolMEMO2020

Identifier Type: -

Identifier Source: org_study_id