Chronic Cerebral IschemiaPhase 3MEMONCT06834490
Safety and Efficacy of Sequential Therapy With Mexidol® in Patients With Chronic Cerebral Ischemia
A Phase 3 study testing Mexidol in people with Chronic Cerebral Ischemia, run by Pharmasoft at 14 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate safety and efficacy of sequential treatment with Mexidol® in patients with chronic cerebral ischemia (CCI). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Cerebral Ischemia
- What is being tested?
- Mexidol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 318 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 5 Nov 2019to 8 Dec 2020
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Inclusion by mistake (overlooked inclusion or non-inclusion criteria)
- 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
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- 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.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Russia13 sites
Municipal Autonomous Healthcare Insitution of the Order of the Red Banner of Labour "City Clinical Hospital No.1"
Chelyabinsk, 454092
Regional Budget Healthcare Institution "Ivanovo Regional Clinical Hospital"
Ivanovo, 152040
Federal State Budget Educational Institution of Higher Education "Kazan State Medical University"
Kazan', 420012
Federal State Budget Research Institution "Research Center of Neurology"
Moscow, 125367
Federal State Budget Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education"
Moscow, 125445
State Budget Healthcare Institution of the Novosibirsk Region "City Hospital № 34"
Novosibirsk, 630054
Federal State Budget Research Institution "Federal Research Center for Fundamental and Translational Medicine"
Novosibirsk, 630117
Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy n.a. S.M.Kirov"
Saint Petersburg, 194044
City Hospital No.40 of the Kurortny District
Sestroretsk, 197706
Private Healthcare Institution "Clinical Hospital "RR-Medicine" of Voronezh
Voronezh, 394024
OOO "Centre for Evidence-Based Medicine"
Yaroslavl, 150000
State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"
Yaroslavl, 150030
State Budget Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"
Yekaterinburg, 620102
Uzbekistan1 site
Centre for Neurology and Neurorehabilitation n.a. N. M. Madzhido, OOO "Neyromed Servis"
Tashkent, 100187
About this study
Official title: International Multicentre Randomized, Double-blind, Placebo-controlled Adaptive Design Clinical Trial to Evaluate the Safety and Efficacy of Sequential Therapy With Mexidol® Solution for Intravenous and Intramuscular Administration, 50 mg/ml (RPC PHARMASOFT LLC, Russia) and Mexidol® FORTE 250 Film-coated Tablets, 250 mg (RPC PHARMASOFT LLC, Russia) in Patients With Chronic Cerebral Ischemia (MEMO)
The purpose of this study is to evaluate safety and efficacy of sequential treatment with Mexidol® in patients with chronic cerebral ischemia (CCI).
Read the 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
- Being tested
- Mexidol, Placebo
- 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
- Medical subject headings
- Ischemia, Stroke, Neurobehavioral Manifestations, Cerebrovascular Disorders, Central Nervous System Diseases, Cognitive Dysfunction, Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MexidolDrug
Also called Ethylmethylhydroxypyridine Succinate
50 mg/ml IV solution, 250 mg tablets
PlaceboDrug
Placebo IV solution, Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Montreal Cognitive Assessment (MoCA) is used to measure the changes in the severity of cognitive impairment at Visits 2 and 4 in comparison to Visit 0. 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.
Measured: 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)
The SF-36 questionnaire is used between Visit 1 and Visits 2, 4, 5. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Measured: 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)
The SF-36 questionnaire is used between Visit 1 and Visits 2, 4, 5. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Measured: 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)
The Multidimensional Fatigue Inventory (MFI-20) is used between Visit 1 and Visits 2, 4, 5. MFI-20 is a 20-item self-administered questionnaire designed to measure fatigue in five four-item subscales: General fatigue, Physical fatigue, Reduced activity, Reduced motivation and Mental fatigue. MFI-20 has an even proportion of positively and negatively worded items that are rated on a 5-point Likert scale. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. Higher scores indicate a higher level of fatigue.
Measured: 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
The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
Measured: 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)
Autonomic Changes According to the A.M.Wein's Questionnaire
The A.M.Wein's questionnaire is used between Visit 1 and Visit 2, 4, 5. It includes 11 main signs of autonomic disorders. Each autonomic symptom is assessed using scores from 7 to 3, then the scores are summed. Scores may range from 0 to 60, higher scores mean a worse outcome. The total sum of the scores in healthy individuals should be 0-14 scores. 15-29 scores are indicative of moderate vegetative dystonia syndrome, 30 and more scores are indicative of severe vegetative dystonia syndrome.
Measured: 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 Cognitive Impairment Assessed With Digit Symbol Substitution Test
The Digit Symbol Substitution Test is used between Visit 1 and Visits 2, 4, 5. The DSST is used to measure attention, processing speed and executive function.
It is a pencil and paper test of psychomotor performance in which the subject is given a key grid of numbers and matching symbols and a test section with numbers and empty boxes. The test consists of filling as many empty boxes as possible with a symbol matching each number. The score is the number of correct number-symbol matches achieved in 90 s. Scores range from 0 to 100, with higher scores indicating higher cognitive function.
Measured: 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)
Motor Changes Assessed With the Tinetti Test
The Tinetti test is used between Visit 1 and Visits 2, 4, 5. The Tinetti test is a clinical test for the assessment of balance and gait. It has a gait score and a balance score using a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling. Tinetti test score equal or less than 18 shows high risk of fall, 19-23 scores show moderate risk of fall, and score equal or higher than 24 shows low risk of fall. Thus, min value is 0, max value is 28, higher scores mean a better outcome.
Measured: 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)
Change in Global Illness Severity Assessed With the Clinical Global Impressions Scale at Visit 5 Compared to Baseline Measure
The Clinical Global Impressions Scale is a standardized assessment tool used to rate the severity of illness, change over time, and efficacy of medication.
The interpretation of scores is as follows:
00 - Not assessed
01 - Vast improvement. Side effects - None. 03 - Vast improvement. Side effects - Significantly interfere with patient's therapeutic patient's functioning 04 - Vast improvement. Side effects - outweights therapeutic effect 05 - Decided improvement. Side effects - none 09 - Slight improvement. Side effects - none 10 - Slight improvement. Side effects - do not significantly interfere with patient's functioning 13 - Slight improvement. Side effects - none
Measured: Day 75+2 (Visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start5 Nov 2019
- Primary completion8 Dec 2020
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Cerebral IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmasoft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alina S. Agafina, MD, Cand.Med.Sci, Principal investigator, Saint Petersburg State Budget Healthcare Institution "City Hospital No.40 of the Kurortny District"Elena V. Vostrikova, MD, Cand.Med.Sci, Principal investigator, State Budget Healthcare Institution of the Nivisibirsk Region "City Hospital No.34"Andrey M. Alasheev, MD, Dr.Med.Sci, Principal investigator, State Budget Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"Marine M. Tanashyan, Prof., Dr.Med.Sci, Principal investigator, Federal State Budget Research Institution "Research Center of Neurology"Min G. Omelyanenko, MD, Dr.Med.Sci, Principal investigator, Regional Budget Healthcare Institution "Ivanovo Regional Clinical Hospital"Stanislav O. Pozdnyakov, MD, Cand.Med.Sci, Principal investigator, OOO "Centre for Evidence-Based Medicine"Aleksandr Y. Malygin, MD, Dr.Med.Sci, Principal investigator, State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"Aida A. Yakupova, MD, Cand.Med.Sci, Principal investigator, Federal State Budget Educational Institution of Higher Education "Kazan State Meical University"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834490
- Sponsor's protocol ID
- MexidolMEMO2020
- Other IDs
- PHS-CICADIS-005-MEX-SOL-TAB
- Acronym
- MEMO
- Status last verified
- Sep 2025
- First submitted
- 11 Feb 2025
- Last updated
- 6 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No