A Phase 3 interventional study of Mexidol and Placebo in Chronic Cerebral Ischemia, sponsored by Pharmasoft. Completed at 14 sites in 2 countries. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Pharmasoft · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate safety and efficacy of sequential treatment with Mexidol® in patients with chronic cerebral ischemia (CCI).
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.
545 studies on the registry are indexed under Ischemia; 72 are open to participants now.
This study's enrollment of 318 is above the median of 74 across 356 interventional studies indexed under Ischemia.
Browse Ischemia studies →Pharmasoft is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
50 mg/ml IV solution, 250 mg tablets
Also known as: Ethylmethylhydroxypyridine Succinate
Placebo IV solution, Placebo tablets
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.
Time frame: Day 75+2 (Visit 5) compared with the baseline level (Visit 0, 7 days before treatment)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Day 75+2 (Visit 5)
Participants were recruited based on protocol requirements at 15 clinical sites between November 2019 and December 2020. The first participant was enrolled on 05 November, 2019 and the last participant was enrolled on 14 September, 2020.
| Milestone | Main (Mexidol) | Control (Placebo) |
|---|---|---|
| Started | 159 | 159 |
| Completed | 157 | 155 |
| Not completed | 2 | 4 |
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.
| score on a scale | Main (Mexidol) | Control (Placebo) |
|---|---|---|
| MoCA Scores at Visit 5 | 25.72 ± 2.47 | 23.95 ± 2.58 |
| Difference in comparison with Visit 0 | 4.22 ± 2.59 | 2.17 ± 2.20 |
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.
| score on a scale | Main (Mexidol) | Control (Placebo) |
|---|---|---|
| MoCA scores at Visit 2 | 23.82 ± 2.28 | 23.10 ± 2.17 |
| Difference at Visit 2 in comparison to Visit 0 | 2.30 ± 1.96 | 1.31 ± 1.64 |
| MoCA scores at Visit 4 | 25.06 ± 2.37 | 23.75 ± 2.34 |
| Difference at Visit 4 in comparison to Visit 0 | 3.54 ± 2.36 | 1.98 ± 2.00 |
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.
| score on a scale | Main (Mexidol) | Control (Placebo) |
|---|---|---|
| SF-36: physical health (Visit 2) | 44.81 ± 8.28 | 44.94 ± 7.83 |
| Difference at Visit 2 in comparison with Visit 1 | 0.60 ± 5.29 | 0.79 ± 4.53 |
| SF-36: physical health (Visit 4) | 46.52 ± 7.90 | 46.07 ± 7.78 |
| Difference at Visit 4 in comparison with Visit 1 | 2.35 ± 6.07 | 2.03 ± 5.60 |
| SF-36: physical health (Visit 5) | 47.31 ± 7.96 | 46.27 ± 7.77 |
| Difference at Visit 5 in comparison with Visit 1 | 3.08 ± 6.70 | 2.23 ± 5.79 |
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.
| score on a scale | Main (Mexidol) | Control (Placebo) |
|---|---|---|
| SF-36: mental health (Visit 2) | 46.64 ± 8.91 | 46.40 ± 9.16 |
| Difference at Visit 2 in comparison with Visit 1 | 2.52 ± 6.75 | 1.49 ± 4.70 |
| SF-36: mental health (Visit 4) | 48.46 ± 8.74 | 47.38 ± 9.14 |
| Difference at Visit 4 in comparison with Visit 1 | 4.30 ± 7.85 | 2.45 ± 6.46 |
| SF-36: mental health (Visit 5) | 50.51 ± 7.96 | 48.40 ± 8.77 |
| Difference at Visit 5 in comparison with Visit 1 | 6.36 ± 8.14 | 3.46 ± 8.05 |
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.
| score on a scale | Main (Mexidol) | Control (Placebo) |
|---|---|---|
| MFI-20 scores at Visit 2 | 56.51 ± 13.71 | 57.14 ± 13.79 |
| Difference at Visit 2 in comparison with Visit 1 | -3.26 ± 9.58 | -1.68 ± 7.24 |
| MFI-20 scores at Visit 4 | 53.44 ± 14.20 | 55.23 ± 14.14 |
| Difference at Visit 4 in comparison with Visit 1 | -6.37 ± 11.61 | -3.81 ± 10.15 |
| MFI-20 scores at Visit 5 | 51.47 ± 13.89 | 54.24 ± 14.00 |
| Difference at Visit 5 in comparison with Visit 1 | -8.33 ± 12.68 | -4.80 ± 11.42 |
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).
| score on a scale | Main (Mexidol) | Control (Placebo) |
|---|---|---|
| BAI scores at Visit 2 | 9.97 ± 8.10 | 10.08 ± 7.23 |
| Difference at Visit 2 in comparison with Visit 1 | -1.88 ± 5.10 | -1.11 ± 5.54 |
| BAI scores at Visit 4 | 8.10 ± 7.04 | 9.14 ± 7.13 |
| Difference at Visit 4 in comparison with Visit 1 | -3.77 ± 5.09 | -2.02 ± 5.98 |
| BAI scores at Visit 5 | 7.07 ± 6.42 | 8.90 ± 7.15 |
| Difference at Visit 5 in comparison with Visit 1 | -4.70 ± 5.49 | -2.26 ± 7.10 |
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.
| score on a scale | Main (Mexidol) | Control (Placebo) |
|---|---|---|
| Wein's questionnaire, Visit 2 | 23.58 ± 13.68 | 24.11 ± 12.61 |
| Difference at Visit 2 in comparison with Visit 1 | -3.01 ± 7.71 | -2.18 ± 8.01 |
| Wein's questionnaire, Visit 4 | 21.37 ± 13.80 | 22.89 ± 12.61 |
| Difference at Visit 4 in comparison with Visit 1 | -5.23 ± 9.19 | -3.42 ± 10.23 |
| Wein's questionnaire, Visit 5 | 19.70 ± 13.92 | 22.01 ± 13.07 |
| Difference at Visit 5 in comparison with Visit 1 | -6.76 ± 10.94 | -4.30 ± 10.81 |
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.
| score on a scale | Main (Mexidol) | Control (Placebo) |
|---|---|---|
| DSST, Visit 2 | 36.94 ± 10.82 | 36.33 ± 11.84 |
| Difference at Visit 2 in comparison with Visit 1 | 4.11 ± 6.63 | 2.61 ± 7.18 |
| DSST, Visit 4 | 39.80 ± 10.78 | 37.89 ± 11.78 |
| Difference at Visit 4 in comparison with Visit 1 | 6.91 ± 8.10 | 4.24 ± 8.77 |
| DSST, Visit 5 | 42.72 ± 12.53 | 39.05 ± 12.36 |
| Difference at Visit 5 in comparison with Visit 1 | 9.84 ± 10.50 | 5.40 ± 10.15 |
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.
| score on a scale | Main (Mexidol) | Control (Placebo) |
|---|---|---|
| Tinetti test, Visit 2 | 34.26 ± 4.92 | 34.00 ± 4.75 |
| Difference at Visit 2 in comparison with Visit 1 | 1.62 ± 2.47 | 0.71 ± 2.84 |
| Tinetti test, Visit 4 | 35.06 ± 4.57 | 34.39 ± 4.47 |
| Difference at Visit 4 in comparison with Visit 1 | 2.44 ± 3.20 | 1.18 ± 3.51 |
| Tinetti test, Visit 5 | 35.97 ± 4.26 | 34.75 ± 4.42 |
| Difference at Visit 5 in comparison with Visit 1 | 3.36 ± 3.39 | 1.55 ± 4.05 |
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
| Participants | Main (Mexidol) | Control (Placebo) |
|---|---|---|
| 01 | 45 | 7 |
| 03 | 1 | 0 |
| 04 | 0 | 1 |
| 05 | 39 | 16 |
| 09 | 54 | 56 |
| 10 | 3 | 0 |
| 13 | 15 | 75 |
Collected over From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Main (Mexidol) | 0/159 (0%) | 0/159 (0%) | 19/159 (11.9%) |
| Control (Placebo) | 0/159 (0%) | 0/159 (0%) | 32/159 (20.1%) |
| Event | Main (Mexidol) | Control (Placebo) |
|---|---|---|
| Itchy throatRespiratory, thoracic and mediastinal disorders | 4/159 | 0/159 |
| Respiratory infectionRespiratory, thoracic and mediastinal disorders | 1/159 | 3/159 |
| High levels of alanine aminotransferaseInvestigations | 0/159 | 3/159 |
| DyspepsiaGastrointestinal disorders | 2/159 | 1/159 |
| Itchy noseRespiratory, thoracic and mediastinal disorders | 2/159 | 0/159 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/159 | 1/159 |
| DysgeusiaRespiratory, thoracic and mediastinal disorders | 2/159 | 0/159 |
| DizzinessNervous system disorders | 1/159 | 2/159 |
| High blood pressureCardiac disorders | 0/159 | 2/159 |
| High levels of aspartate aminotransferaseInvestigations | 0/159 | 2/159 |
ITT-population was used for description of baseline measures.
| Age, Categorical(Participants) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 104 | 99 | 203 |
| >=65 years | 55 | 60 | 115 |
| Age, Continuous(Years) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|
| Mean | 60.08 ± 9.86 | 60.73 ± 9.03 | 60.44 ± 9.59 |
| Sex: Female, Male(Participants) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|
| Female | 119 | 121 | 240 |
| Male | 40 | 38 | 78 |
| Race (NIH/OMB)(Participants) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 10 | 8 | 18 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 149 | 151 | 300 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|
| Russia | 151 | 151 | 302 |
| Uzbekistan | 8 | 8 | 16 |
| The Montreal Cognitive Assessment scores at Visit 0 (7 days before treatment)(score on a scale) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|
| Mean | 21.53 ± 2.27 | 21.80 ± 1.96 | 21.67 ± 2.13 |
| The SF-36 questionnaire scores at Visit 1 (Day 1 of treatment)(score on a scale) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|
| The SF-36 questionnaire: physical health | 44.21 ± 8.58 | 44.12 ± 7.92 | 44.21 ± 8.28 |
| The SF-36 questionnaire: mental health | 44.12 ± 9.18 | 44.95 ± 9.20 | 44.51 ± 9.18 |
| The Multidimensional Fatigue Inventory scores at Visit 1 (Day 1 of treatment)(score on a scale) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|
| Mean | 59.77 ± 13.35 | 58.79 ± 13.78 | 59.25 ± 13.55 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2019 to primary completion in Dec 2020, 13 months.
Results were first posted in Oct 2025, 4 years 9 months after primary completion.
Of 12 phase 3 interventional studies under Ischemia, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 51. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Emoxypine succinate
Pharmasoft