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| ID | Type | Description | Link |
|---|---|---|---|
| PHS-CICADIS-005-MEX-SOL-TAB | Other Identifier | Pharmasoft |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mexidol | Drug | 50 mg/ml IV solution, 250 mg tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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" |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Municipal Autonomous Healthcare Insitution of the Order of the Red Banner of Labour "City Clinical Hospital No.1" | Chelyabinsk | 454092 | Russia |
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Of 330 screened participants, 318 met inclusion criteria and were randomized to treatment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ITT-population was used for description of baseline measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control (Placebo) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Patients aged from 40 to 90 years inclusive were enrolled |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Posted | Mean | Standard Deviation | score on a scale | Day 75+2 (Visit 5) compared with the baseline level (Visit 0, 7 days before treatment) |
|
From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Y.E. Meshcherskiy, Medical Director | Pharmasoft | + 7 (495) 626-47- 55 | 140 | meshcherskiy_y@pharmasoft.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2020 | May 16, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2020 | Apr 4, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| D020521 | Stroke |
| D019954 | Neurobehavioral Manifestations |
| D002561 | Cerebrovascular Disorders |
| D002493 | Central Nervous System Diseases |
| D060825 | Cognitive Dysfunction |
| D002534 | Hypoxia, Brain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C070020 | emoxypine succinate |
| C517040 | ethylmethylhydroxypyridine succinate |
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| Placebo | Drug | Placebo IV solution, Placebo tablets |
|
| 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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 | Day 75+2 (Visit 5) |
| 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 |
| Regional Budget Healthcare Institution "Ivanovo Regional Clinical Hospital" | Ivanovo | 152040 | Russia |
| Federal State Budget Educational Institution of Higher Education "Kazan State Medical University" | Kazan' | 420012 | Russia |
| Federal State Budget Research Institution "Research Center of Neurology" | Moscow | 125367 | Russia |
| Federal State Budget Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education" | Moscow | 125445 | Russia |
| State Budget Healthcare Institution of the Novosibirsk Region "City Hospital № 34" | Novosibirsk | 630054 | Russia |
| Federal State Budget Research Institution "Federal Research Center for Fundamental and Translational Medicine" | Novosibirsk | 630117 | Russia |
| Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy n.a. S.M.Kirov" | Saint Petersburg | 194044 | Russia |
| City Hospital No.40 of the Kurortny District | Sestroretsk | 197706 | Russia |
| Private Healthcare Institution "Clinical Hospital "RR-Medicine" of Voronezh | Voronezh | 394024 | Russia |
| OOO "Centre for Evidence-Based Medicine" | Yaroslavl | 150000 | Russia |
| State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2" | Yaroslavl | 150030 | Russia |
| State Budget Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1" | Yekaterinburg | 620102 | Russia |
| Centre for Neurology and Neurorehabilitation n.a. N. M. Madzhido, OOO "Neyromed Servis" | Tashkent | 100187 | Uzbekistan |
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
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | There were 302 participants from Russia and 16 participants from Uzbekistan. 302 plus 16 equals 318 (ITT-population). | Count of Participants | Participants | No |
|
| The Montreal Cognitive Assessment scores at Visit 0 (7 days before treatment) | 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. | The results obtained at Visit 0 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Mean | Standard Deviation | score on a scale |
|
| The SF-36 questionnaire scores at Visit 1 (Day 1 of treatment) | The SF-36 questionnaire has two summary measures: physical and mental health. The scoring ranges from 0 to 100. Higher scores indicate better health status. | The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Mean | Standard Deviation | score on a scale |
|
| The Multidimensional Fatigue Inventory scores at Visit 1 (Day 1 of treatment) | 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. | The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Mean | Standard Deviation | score on a scale |
|
| The Beck Anxiety Inventory scores at Visit 1 (Day 1 of treatment) | 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). | The results obtained at Visit 1 were used as reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Mean | Standard Deviation | score on a scale |
|
| A.M.Wein's questionnaire scores at Visit 1 (Day 1 of treatment) | 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 3 to 7, 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. | The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Mean | Standard Deviation | score on a scale |
|
| The Digit Symbol Substitution Test scores at Visit 1 (Day 1 of treatment) | 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. | The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Mean | Standard Deviation | score on a scale |
|
| The Tinetti test scores at Visit 1 (Day 1 of treatment) | 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. | The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Mean | Standard Deviation | score on a scale |
|
| OG001 | 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 |
|
|
| Secondary | 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. | The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Posted | Mean | Standard Deviation | score on a scale | Day 14 (Visit 2) and Day 44±2 (Visit 4) compared with the baseline level (Visit 0, 7 days before treatment) |
|
|
|
| Secondary | 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. | The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| Secondary | 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. | The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| Secondary | 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. | The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| Secondary | 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). | The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| Secondary | 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. | The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| Secondary | 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. | The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| Secondary | 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. | The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| Secondary | 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 | The analysis was performed for the PP-population (312 participants). | Posted | Count of Participants | Participants | Day 75+2 (Visit 5) |
|
|
|
| 0 |
| 159 |
| 0 |
| 159 |
| 19 |
| 159 |
| EG001 | 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 | 0 | 159 | 0 | 159 | 32 | 159 |
| Respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Itchy nose | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Itchy throat | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Backache | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Dysgeusia | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Viral pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| High blood pressure | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
|
| High levels of alanine aminotransferase | Investigations | MedDRA version 23.1 | Systematic Assessment |
|
| High levels of aspartate aminotransferase | Investigations | MedDRA version 23.1 | Systematic Assessment |
|
| High levels of blood creatinine | Investigations | MedDRA version 23.1 | Systematic Assessment |
|
| High levels of blood urea | Investigations | MedDRA version 23.1 | Systematic Assessment |
|
| Limb pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Hyperoxaluria | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Right bundle branch block | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Heart palpitation | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Hyperemia | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Burning sensation | General disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
|
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| MoCA scores at Visit 4 |
|
| Difference at Visit 4 in comparison to Visit 0 |
|
| SF-36: physical health (Visit 4) |
|
| Difference at Visit 4 in comparison with Visit 1 |
|
| SF-36: physical health (Visit 5) |
|
| Difference at Visit 5 in comparison with Visit 1 |
|
| SF-36: mental health (Visit 4) |
|
| Difference at Visit 4 in comparison with Visit 1 |
|
| SF-36: mental health (Visit 5) |
|
| Difference at Visit 5 in comparison with Visit 1 |
|
| MFI-20 scores at Visit 4 |
|
| Difference at Visit 4 in comparison with Visit 1 |
|
| MFI-20 scores at Visit 5 |
|
| Difference at Visit 5 in comparison with Visit 1 |
|
| BAI scores at Visit 4 |
|
| Difference at Visit 4 in comparison with Visit 1 |
|
| BAI scores at Visit 5 |
|
| Difference at Visit 5 in comparison with Visit 1 |
|
| Wein's questionnaire, Visit 4 |
|
| Difference at Visit 4 in comparison with Visit 1 |
|
| Wein's questionnaire, Visit 5 |
|
| Difference at Visit 5 in comparison with Visit 1 |
|
| DSST, Visit 4 |
|
| Difference at Visit 4 in comparison with Visit 1 |
|
| DSST, Visit 5 |
|
| Difference at Visit 5 in comparison with Visit 1 |
|
| Tinetti test, Visit 4 |
|
| Difference at Visit 4 in comparison with Visit 1 |
|
| Tinetti test, Visit 5 |
|
| Difference at Visit 5 in comparison with Visit 1 |
|
| 04 |
|
| 05 |
|
| 09 |
|
| 10 |
|
| 13 |
|