Clinical trial NCT06834490: Safety and Efficacy of Sequential Treatment with Mexidol® in Patients with Chronic Cerebral Ischemia
Official title: International Multicenter Randomized Double-blind Placebo-controlled Adaptive Design Study to Evaluate Safety and Efficacy of Sequential Treatment with Mexidol® Solution for Intravenous and Intramuscular Administration, 50 Mg/ml (OOO "NPK "PHARMASOFT", Russia) and Mexidol® FORTE 250 Film-coated Tablets, 250 Mg (OOO "NPK "PHARMASOFT", Russia) in Patients with Chronic Cerebral Ischemia (MEMO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Pharmasoft
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 318
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Exclusion Criteria:

1. Inclusion by mistake (overlooked inclusion or non-inclusion criteria)
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.

Primary outcomes:
measure: Mean Score of Montreal Cognitive Assessment (MoCA) at Visit 5 in comparison with reference score at Visit 0
timeFrame: up to 83 days
Secondary outcomes:
measure: Changes in the severity of cognitive impairment assessed with the Montreal Cognitive Assessment scale between Visit 0 and Visits 2 and 4
timeFrame: up to 83 days
measure: Changes in patients' quality of life assessed with SF-36 questionnaire
timeFrame: up to 83 days
measure: Changes in the severity of asthenia assessed with the Multidimensional Fatigue Inventory (MFI-20)
timeFrame: up to 83 days
measure: Changes in the anxiety level according to the Beck Anxiety Inventory
timeFrame: up to 83 days
measure: Autonomic changes according to the A.M.Wein's questionnaire
timeFrame: up to 83 days
measure: Changes in cognitive impairment assessed with Digit Symbol Substitution Test
timeFrame: up to 83 days
measure: Motor changes assessed with the Tinetti test
timeFrame: up to 83 days
measure: Changes in global illness severity assessed with the Clinical Global Impressions Scale
timeFrame: up to 83 days
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Municipal Autonomous Healthcare Insitution of the Order of the Red Banner of Labour "City Clinical Hospital No.1"
city: Ekaterinburg
country: Russian Federation
facility: State Budget Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"
city: Ivanovo
country: Russian Federation
facility: Regional Budget Healthcare Institution "Ivanovo Regional Clinical Hospital"
city: Kazan
country: Russian Federation
facility: Federal State Budget Educational Institution of Higher Education "Kazan State Medical University"
city: Moscow
country: Russian Federation
facility: Federal State Budget Research Institution "Research Center of Neurology"
city: Moscow
country: Russian Federation
facility: Federal State Budget Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education"
city: Novosibirsk
country: Russian Federation
facility: State Budget Healthcare Institution of the Novosibirsk Region "City Hospital № 34"
city: Novosibirsk
country: Russian Federation
facility: Federal State Budget Research Institution "Federal Research Center for Fundamental and Translational Medicine"
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy n.a. S.M.Kirov"
city: Sestroretsk
country: Russian Federation
facility: City Hospital No.40 of the Kurortny District
city: Voronezh
country: Russian Federation
facility: Private Healthcare Institution "Clinical Hospital "RR-Medicine" of Voronezh
city: Yaroslavl
country: Russian Federation
facility: OOO "Centre for Evidence-Based Medicine"
city: Yaroslavl
country: Russian Federation
facility: State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"
city: Tashkent
country: Uzbekistan
facility: Centre for Neurology and Neurorehabilitation n.a. N. M. Madzhido, OOO "Neyromed Servis"
Study officials:
affiliation: Saint Petersburg State Budget Healthcare Institution "City Hospital No.40 of the Kurortny District"
name: Alina S. Agafina, MD, Cand.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: State Budget Healthcare Institution of the Nivisibirsk Region "City Hospital No.34"
name: Elena V. Vostrikova, MD, Cand.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: State Budget Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"
name: Andrey M. Alasheev, MD, Dr.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Budget Research Institution "Research Center of Neurology"
name: Marine M. Tanashyan, Prof., Dr.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Budget Healthcare Institution "Ivanovo Regional Clinical Hospital"
name: Min G. Omelyanenko, MD, Dr.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: OOO "Centre for Evidence-Based Medicine"
name: Stanislav O. Pozdnyakov, MD, Cand.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"
name: Aleksandr Y. Malygin, MD, Dr.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Budget Educational Institution of Higher Education "Kazan State Meical University"
name: Aida A. Yakupova, MD, Cand.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy n.a. S.M.Kirov"
name: Igor V. Litvinenko, Prof., Dr.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: Municipal Autonomous Healthcare Insitution of the Order of the Red Banner of Labour "City Clinical Hospital No.1"
name: Irina G. Lukashevich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"
name: Olga A. Sinitsyna, MD, Cand.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Budget Research Institution "Federal Research Center for Fundamental and Translational Medicine"
name: Larisa A. Shchepankevich, MD, Dr.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Healthcare Institution "Clinical Hospital "RR-Medicine" of Voronezh
name: Galina A. Batishcheva, Prof., Dr.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Budget Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education"
name: Olga D. Ostroumova, Prof., Dr.Med.Sci
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Neurology and Neurorehabilitation n.a. N.M.Madzhido, OOO "Neyromed Servis"
name: Yokutkhon N. Madzhidova, Prof., Dr.Med.Sci
role: PRINCIPAL_INVESTIGATOR
References: