Cognitive Disorders
Conditions
Brief summary
The clinical trial to valuate efficacy and safety of MMH-MAP in the treatment of cognitive disorders in patients with ischemic stroke in the carotid arteries.
Detailed description
Design: double-blind, randomized, parallel group placebo-controlled clinical study of efficacy and safety of MMH-MAP in the treatment of cognitive disorders in patients with ischemic stroke in the carotid arteries. The study will enroll hospitalized subjects of either gender aged 40-75 years old with verified diagnosis of ischemic stroke in the carotid arteries within 72 hours post debut having moderate cognitive disorders, moderate neurological deficit. At Visit 1 (day 1) the subject's complaints and medical history will be collected, objective examination, safety laboratory tests (hematology, serum chemistry, urinalysis) will be performed. The investigator will evaluate the patient's level of consciousness using The Glasgow Coma Scale, intensity of cognitive disorders using The Montreal Cognitive Assessment (МоСА), condition using National Institute of Health Stroke Scale (NIHSS) and The Modified Rankin Scale (mRs). Concomitant therapy will be recorded and changes in cerebral CT/MRI will be evaluated. If the subject meets inclusion criteria and has no exclusion criteria, he/she will be randomized to MMH-MAP or Placebo group. The first dose of the study product should be taken within 72 hours post stroke debut. At Visit 2 (day 12±3, end of hospitalization period - the last day of hospitalization due to the current stroke) complaints will be collected, objective examination findings will be recorded, monitoring of the prescribed and concomitant therapy will be performed, treatment safety, compliance and stroke severity according to NIHSS will be evaluated. By the end of hospital therapy the subject will be switched to outpatient therapy with continuation of IMP and medical assistance designed for the treatment of stroke and its sequelae. At Visit 3 (day 45±7 days) the investigator will make a phone call to the subject evaluating the treatment safety. At final Visit 4 (day 90±7 days) complaints will be collected, objective examination findings will be recorded, monitoring of the prescribed and concomitant therapy will be performed, treatment safety, compliance, condition according to NIHSS will be evaluated, mRs, Clinical Global Impression Efficacy Index (CGI-EI) will be filled. The investigator will perform MoCA testing. Safety laboratory tests (hematology, serum chemistry, urinalysis) will be carried out. Throughout the study the patient will receive the treatment approved by the decree of the RF Ministry of Health dated 29.12.2012 No. 740n On approval of standard of special care in cerebral infarction except for the products specified in section Forbidden concomitant therapy.
Interventions
DRUGMMH-MAP
Oral administration
DRUGPlacebo
Oral administration
Sponsors
Materia Medica Holding
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 40 and 75 years old inclusively. 2. Ischemic stroke in the carotid arteries (I 63) within 72 hours post debut. 3. Moderate cognitive disorders (MoCA \< 26). 4. Normal consciousness (Glasgow score 15) 5. Stroke severity 8-12 according to NIHSS. 6. Disability mRs score 2-3. 7. Availability of cerebral CT/MRI within 72 hours post stroke debut. 8. Patients who agreed to use a reliable method of contraception during the study. 9. Patients who have signed the Participant Information Sheet and Informed Consent.
Exclusion criteria
1. Current or previous subarachnoidal/parenchymatous/ventricular hemorrhage, cerebral infarction, cerebral tumour. 2. Cerebral CT/MRI findings suggesting cerebral hemorrhage, tumour within 72 hours post stroke debut. 3. Scheduled or completed thrombolytic therapy for the treatment of the current cerebral infarction. 4. Central nervous system (CNS) diseases including: * Inflammatory diseases of the central nervous system (G00-G09); * Systemic atrophies primarily affecting the central nervous system (G10-G13); * Extrapyramidal and movement disorders (G20-G26); * Other degenerative diseases of the nervous system (G30-G32); * Demyelinating diseases of the CNS (G35-G37); * Episodic and paroxysmal disorders (G40-G47); * Polyneuropathies and other disorders of the peripheral nervous system (G60-64), with marked movement and/or sensory impairments that cause movement disorders; * Hydrocephalus (G91). 5. Head injuries (S00-S09) (including history), accompanied by impaired consciousness, brain contusion or open craniocerebral injuries. 6. Musculoskeletal disorders causing motor disturbances. 7. Dementia (including history) (F00-F03). 8. Malignant neoplasms. 9. Patients previously diagnosed with class IV heart failure (1964 New York Heart Association functional classification), hypothyroidism, or poorly treated diabetes mellitus. 10. Patients having unstable angina or myocardial infarction in the past 6 months. 11. Allergy/ intolerance to any of the components of medications used in the treatment. 12. Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency) and galactosemia. 13. Any conditions which, according to the investigator opinion, may interfere with the subject's participation in the study. 14. Prior history of non-adherence to a drug regimen, a psychiatric disorder, alcoholism or drug abuse, which, in the opinion of the investigator, can compromise compliance with study protocol. 15. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial. 16. Participation in other clinical studies within 3 month prior to enrollment in the study. 17. Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted). 18. Patients who work for OOO NPF Materia Medica Holding (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average MoCA Score. | On baseline and on 90th day of the treatment. | Montreal Cognitive Assessment Scale (The Montreal Cognitive Assessment, MoCA) will be used to identify moderate cognitive impairment, as well as to assess changes in cognitive functions during therapy. The maximum possible number of points is 30; 26 points or more is considered normal. The minimum score is 0, higher score is better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in NIHSS Score. | On baseline, on 12th and on 90th days of the treatment. | NIHSS Scale (National Institutes of Health Stroke Scale) is a scale for assessing the severity of neurological disorders of the acute period of ischemic stroke. The NIHSS scale involves the assessment of a neurological condition by generally accepted methods of clinical examination of reflexes, sensory organs, and the patient's level of consciousness. The results range from minimum indicators - normal or close to normal, to maximum - reflect the degree of neurological damage. The score varies between 0 and 42, lower score is better. |
| Percentage of Patients With no Significant Disabilities. | On 90th day of the treatment. | The modified Rankin scale (mRs 0-1) allows to assess the grade of disability after a stroke. The scale includes five grades of disability: from 0 to 5: 0 - no symptoms, 5 - gross disability; bedridden, fecal and urinary incontinence, need for constant assistance by medical staff. |
| Therapeutic and Side Effects, Efficacy Index. | On 90th day of the treatment period. | According to Clinical Global Impression Efficacy Index (CGI-EI).CGI-EI is filled out by an investigator. It is necessary to indicate the level of efficacy of the therapy and the grade of safety of the therapy and circle the index values at the intersection of the selected lines. Evaluation of the response to treatment should take into account both therapeutic efficacy and treatment-related side effects. Side effects score varies from 1 to 4 (lower is better). Therapeutic effect score varies from 1 to 4 (higher is better). The efficacy index is Therapeutic effect score divided by Side effects score, so efficacy index varies from 0.25 to 4 (higher is better). |
| Presence of Adverse Events (AEs). | For 90 days of the treatment period. | Based on medical records. Outcome measure represents the amount of participants having at least one adverse event on record. |
| Percentage of Patients With Complication of Cerebral Infarction. | For 90 days of the treatment period. | Based on medical records. The sequelae of cerebral infarction (severe infections - hospital-acquired pneumonia, uroinfection; deep venous thrombosis, PATE; epileptic episodes). |
| Death Rate. | For 90 days of the treatment period. | Based on medical records. Frequency of all-cause mortality outcomes. |
| Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90) | Based on medical records. Vital signs will be measured in a medical setting. |
| Changes in Vital Signs (Blood Pressure). | Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90). | Based on medical records. Vital signs are measured in a medical setting. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented. |
| Percentage of Patients With Clinically Significant Abnormal Laboratory Data. | On baseline and on 90th day of the treatment. | Based on medical records. Laboratory tests include the following parameters (absolute and relative values): hematology, biochemistry and urinalysis. Laboratory tests will be made by central laboratory. Hemoglobin: less than or equal to (\<=) 115 grams per liter (g/L); greater than or equal to (\>=)185 g/L; decreased from baseline (DFB) \>=20 g/L Hematocrit: \<=0.37 volume/volume (v/v); \>=0.55 v/v Erythrocytes: \>=6 Tera/L Leukocytes: \>=16.0 Giga/L Neutrophils: \<1.0 Giga/L (B); Lymphocytes: greater than (\>) 4.0 Giga/L Monocytes: \>0.7 Giga/L Basophils: \>0.1 Giga/L Eosinophils: \>0.5 Giga/L or \>upper limit of normal (ULN) (if ULN \>=0.5 Giga/L) Sodium: \<=129 millimoles (mmol)/L; \>=160 mmol/L Potassium: \<3 mmol/L; \>=5.5 mmol/L Alanine Aminotransferase (ALT): \>3 ULN Aspartate aminotransferase (AST): \>3 ULN Alkaline phosphatase: \>1.5 ULN Bilirubin: \>1.5 ULN Creatinine: \>=150 micromoles per liter (mcmol/L); \>=30% change from baseline. |
| Percentage of Patients With Recurring Cerebral Infarction. | For 90 days of the treatment period. | The percentage of patients with recurrent cerebral infarction for 90 days of the treatment period is estimated from medical records. |
| Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90). | Based on medical records. Vital signs will be measured in a medical setting. |
Countries
Russia
Participant flow
Pre-assignment details
A total of 246 patients signed informed consent, of which 1 patient was excluded at the screening due to the patient's refusal to complete the MoCA scale.
Participants by arm
| Arm | Count |
|---|---|
| MMH-MAP Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.
MMH-MAP: Oral administration | 123 |
| Placebo Oral administration. For 90 days according to MMH-MAP dosing regimen.
Placebo: Oral administration | 122 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Eligibility error | 1 | 3 |
Baseline characteristics
| Characteristic | Placebo | Total | MMH-MAP |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 59 Participants | 116 Participants | 57 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 129 Participants | 66 Participants |
| Age, Continuous | 62.5 years STANDARD_DEVIATION 7.9 | 63.0 years STANDARD_DEVIATION 7.7 | 63.6 years STANDARD_DEVIATION 7.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Russia | 122 Participants | 245 Participants | 123 Participants |
| Sex: Female, Male Female | 33 Participants | 82 Participants | 49 Participants |
| Sex: Female, Male Male | 89 Participants | 163 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 123 | 0 / 122 |
| other Total, other adverse events | 32 / 123 | 28 / 122 |
| serious Total, serious adverse events | 4 / 123 | 4 / 122 |
Outcome results
Primary
Average MoCA Score.
Montreal Cognitive Assessment Scale (The Montreal Cognitive Assessment, MoCA) will be used to identify moderate cognitive impairment, as well as to assess changes in cognitive functions during therapy. The maximum possible number of points is 30; 26 points or more is considered normal. The minimum score is 0, higher score is better.
Time frame: On baseline and on 90th day of the treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | Average MoCA Score. | 90th day of the treatment minus baseline score difference | 3.9 score on a scale | Standard Deviation 2.5 |
| MMH-MAP | Average MoCA Score. | Baseline | 20.7 score on a scale | Standard Deviation 3.5 |
| MMH-MAP | Average MoCA Score. | On 90th day of the treatment | 24.6 score on a scale | Standard Deviation 2.9 |
| Placebo | Average MoCA Score. | Baseline | 21.7 score on a scale | Standard Deviation 2.4 |
| Placebo | Average MoCA Score. | On 90th day of the treatment | 24.5 score on a scale | Standard Deviation 3 |
| Placebo | Average MoCA Score. | 90th day of the treatment minus baseline score difference | 2.9 score on a scale | Standard Deviation 2.3 |
Comparison: Mean changes of MoCA scores (90th day of treatment minus baseline) were compared.p-value: 0.000695% CI: [0.47, 1.7]t-test, 2 sided
Secondary
Changes in NIHSS Score.
NIHSS Scale (National Institutes of Health Stroke Scale) is a scale for assessing the severity of neurological disorders of the acute period of ischemic stroke. The NIHSS scale involves the assessment of a neurological condition by generally accepted methods of clinical examination of reflexes, sensory organs, and the patient's level of consciousness. The results range from minimum indicators - normal or close to normal, to maximum - reflect the degree of neurological damage. The score varies between 0 and 42, lower score is better.
Time frame: On baseline, on 12th and on 90th days of the treatment.
Population: The number of completed cases (non-missing data) is indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | Changes in NIHSS Score. | Baseline minus 90th day score difference | 5.6 score on a scale | Standard Deviation 1.7 |
| MMH-MAP | Changes in NIHSS Score. | On 12th day of the treatment | 4.9 score on a scale | Standard Deviation 2 |
| MMH-MAP | Changes in NIHSS Score. | Baseline | 8.6 score on a scale | Standard Deviation 0.8 |
| MMH-MAP | Changes in NIHSS Score. | On 90th day of the treatment | 3.0 score on a scale | Standard Deviation 1.8 |
| MMH-MAP | Changes in NIHSS Score. | Baseline minus 12th day score difference | 3.6 score on a scale | Standard Deviation 1.7 |
| Placebo | Changes in NIHSS Score. | On 90th day of the treatment | 2.9 score on a scale | Standard Deviation 1.8 |
| Placebo | Changes in NIHSS Score. | Baseline minus 12th day score difference | 3.7 score on a scale | Standard Deviation 1.9 |
| Placebo | Changes in NIHSS Score. | Baseline minus 90th day score difference | 5.6 score on a scale | Standard Deviation 2 |
| Placebo | Changes in NIHSS Score. | Baseline | 8.5 score on a scale | Standard Deviation 0.7 |
| Placebo | Changes in NIHSS Score. | On 12th day of the treatment | 4.8 score on a scale | Standard Deviation 1.9 |
Comparison: Mean changes of NIHSS scores (baseline minus 12th day of treatment) were compared.p-value: 0.6795% CI: [-0.58, 0.37]t-test, 2 sided
Comparison: Mean changes of NIHSS scores (baseline minus 90th day of treatment) were compared.p-value: 0.9495% CI: [-0.47, 0.5]t-test, 2 sided
Secondary
Changes in Vital Signs (Blood Pressure).
Based on medical records. Vital signs are measured in a medical setting. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented.
Time frame: Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | Changes in Vital Signs (Blood Pressure). | SBP/Visit 1 (day 1) | 139 mmHg | Standard Deviation 12.6 |
| MMH-MAP | Changes in Vital Signs (Blood Pressure). | SBP/Visit 2 (day 12) | 129 mmHg | Standard Deviation 8.3 |
| MMH-MAP | Changes in Vital Signs (Blood Pressure). | SBP/Visit 4 (day 90) | 129 mmHg | Standard Deviation 7.7 |
| MMH-MAP | Changes in Vital Signs (Blood Pressure). | DBP/Visit 1 (day 1) | 82.9 mmHg | Standard Deviation 7 |
| MMH-MAP | Changes in Vital Signs (Blood Pressure). | DBP/Visit 2 (day 12) | 80.0 mmHg | Standard Deviation 5.5 |
| MMH-MAP | Changes in Vital Signs (Blood Pressure). | DBP/Visit 4 (day 90) | 80.2 mmHg | Standard Deviation 5.3 |
| Placebo | Changes in Vital Signs (Blood Pressure). | DBP/Visit 2 (day 12) | 80.6 mmHg | Standard Deviation 5.7 |
| Placebo | Changes in Vital Signs (Blood Pressure). | SBP/Visit 1 (day 1) | 139.0 mmHg | Standard Deviation 11.2 |
| Placebo | Changes in Vital Signs (Blood Pressure). | DBP/Visit 1 (day 1) | 83.5 mmHg | Standard Deviation 7 |
| Placebo | Changes in Vital Signs (Blood Pressure). | SBP/Visit 2 (day 12) | 130 mmHg | Standard Deviation 7.5 |
| Placebo | Changes in Vital Signs (Blood Pressure). | DBP/Visit 4 (day 90) | 80.0 mmHg | Standard Deviation 6.2 |
| Placebo | Changes in Vital Signs (Blood Pressure). | SBP/Visit 4 (day 90) | 130 mmHg | Standard Deviation 7.8 |
Comparison: Systolic blood pressure. Analysis of varience (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested.p-value: 0.438ANOVA
Comparison: Diastolic blood pressure. Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested.p-value: 0.56ANOVA
Secondary
Changes in Vital Signs (Pulse Rate (Heart Rate)).
Based on medical records. Vital signs will be measured in a medical setting.
Time frame: Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 1 (day 1) | 74.0 beats per minute | Standard Deviation 7.6 |
| MMH-MAP | Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 2 (day 12) | 71.3 beats per minute | Standard Deviation 5.4 |
| MMH-MAP | Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 4 (day 90) | 72.3 beats per minute | Standard Deviation 6.1 |
| Placebo | Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 1 (day 1) | 73.5 beats per minute | Standard Deviation 7.6 |
| Placebo | Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 2 (day 12) | 71.3 beats per minute | Standard Deviation 6.3 |
| Placebo | Changes in Vital Signs (Pulse Rate (Heart Rate)). | Visit 4 (day 90) | 71.4 beats per minute | Standard Deviation 5.4 |
Comparison: Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested.p-value: 0.96ANOVA
Secondary
Changes in Vital Signs (Respiration Rate (Breathing Rate)).
Based on medical records. Vital signs will be measured in a medical setting.
Time frame: Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 1 (day 1) | 16.8 breaths per minute | Standard Deviation 1 |
| MMH-MAP | Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 2 (day 12) | 16.7 breaths per minute | Standard Deviation 1 |
| MMH-MAP | Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 4 (day 90) | 16.8 breaths per minute | Standard Deviation 1.1 |
| Placebo | Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 1 (day 1) | 16.8 breaths per minute | Standard Deviation 0.9 |
| Placebo | Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 2 (day 12) | 16.7 breaths per minute | Standard Deviation 0.9 |
| Placebo | Changes in Vital Signs (Respiration Rate (Breathing Rate)). | Visit 4 (day 90) | 16.8 breaths per minute | Standard Deviation 1 |
Comparison: Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested.p-value: 0.96ANOVA
Secondary
Death Rate.
Based on medical records. Frequency of all-cause mortality outcomes.
Time frame: For 90 days of the treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMH-MAP | Death Rate. | 0 Participants |
| Placebo | Death Rate. | 0 Participants |
Secondary
Percentage of Patients With Clinically Significant Abnormal Laboratory Data.
Based on medical records. Laboratory tests include the following parameters (absolute and relative values): hematology, biochemistry and urinalysis. Laboratory tests will be made by central laboratory. Hemoglobin: less than or equal to (\<=) 115 grams per liter (g/L); greater than or equal to (\>=)185 g/L; decreased from baseline (DFB) \>=20 g/L Hematocrit: \<=0.37 volume/volume (v/v); \>=0.55 v/v Erythrocytes: \>=6 Tera/L Leukocytes: \>=16.0 Giga/L Neutrophils: \<1.0 Giga/L (B); Lymphocytes: greater than (\>) 4.0 Giga/L Monocytes: \>0.7 Giga/L Basophils: \>0.1 Giga/L Eosinophils: \>0.5 Giga/L or \>upper limit of normal (ULN) (if ULN \>=0.5 Giga/L) Sodium: \<=129 millimoles (mmol)/L; \>=160 mmol/L Potassium: \<3 mmol/L; \>=5.5 mmol/L Alanine Aminotransferase (ALT): \>3 ULN Aspartate aminotransferase (AST): \>3 ULN Alkaline phosphatase: \>1.5 ULN Bilirubin: \>1.5 ULN Creatinine: \>=150 micromoles per liter (mcmol/L); \>=30% change from baseline.
Time frame: On baseline and on 90th day of the treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMH-MAP | Percentage of Patients With Clinically Significant Abnormal Laboratory Data. | Baseline | 19 Participants |
| MMH-MAP | Percentage of Patients With Clinically Significant Abnormal Laboratory Data. | On 90th day of the treatment | 2 Participants |
| Placebo | Percentage of Patients With Clinically Significant Abnormal Laboratory Data. | Baseline | 16 Participants |
| Placebo | Percentage of Patients With Clinically Significant Abnormal Laboratory Data. | On 90th day of the treatment | 1 Participants |
Comparison: Comparison at the baseline.p-value: 0.72Fisher Exact
Comparison: Comparison on 90th day of treatment.p-value: 1Fisher Exact
Secondary
Percentage of Patients With Complication of Cerebral Infarction.
Based on medical records. The sequelae of cerebral infarction (severe infections - hospital-acquired pneumonia, uroinfection; deep venous thrombosis, PATE; epileptic episodes).
Time frame: For 90 days of the treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMH-MAP | Percentage of Patients With Complication of Cerebral Infarction. | 2 Participants |
| Placebo | Percentage of Patients With Complication of Cerebral Infarction. | 2 Participants |
p-value: 1Fisher Exact
Secondary
Percentage of Patients With no Significant Disabilities.
The modified Rankin scale (mRs 0-1) allows to assess the grade of disability after a stroke. The scale includes five grades of disability: from 0 to 5: 0 - no symptoms, 5 - gross disability; bedridden, fecal and urinary incontinence, need for constant assistance by medical staff.
Time frame: On 90th day of the treatment.
Population: The number of completed cases (non-missing data) is indicated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMH-MAP | Percentage of Patients With no Significant Disabilities. | 57 Participants |
| Placebo | Percentage of Patients With no Significant Disabilities. | 53 Participants |
Comparison: Test for comparison percentage of patients with no significant disabilities after 90 days of treatment .p-value: 0.89Fisher Exact
Secondary
Percentage of Patients With Recurring Cerebral Infarction.
The percentage of patients with recurrent cerebral infarction for 90 days of the treatment period is estimated from medical records.
Time frame: For 90 days of the treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMH-MAP | Percentage of Patients With Recurring Cerebral Infarction. | 2 Participants |
| Placebo | Percentage of Patients With Recurring Cerebral Infarction. | 1 Participants |
p-value: 1Fisher Exact
Secondary
Presence of Adverse Events (AEs).
Based on medical records. Outcome measure represents the amount of participants having at least one adverse event on record.
Time frame: For 90 days of the treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MMH-MAP | Presence of Adverse Events (AEs). | 32 participants |
| Placebo | Presence of Adverse Events (AEs). | 28 participants |
Comparison: The percentage of participants having at least one adverse event were compared.p-value: 0.656Fisher Exact
Secondary
Therapeutic and Side Effects, Efficacy Index.
According to Clinical Global Impression Efficacy Index (CGI-EI).CGI-EI is filled out by an investigator. It is necessary to indicate the level of efficacy of the therapy and the grade of safety of the therapy and circle the index values at the intersection of the selected lines. Evaluation of the response to treatment should take into account both therapeutic efficacy and treatment-related side effects. Side effects score varies from 1 to 4 (lower is better). Therapeutic effect score varies from 1 to 4 (higher is better). The efficacy index is Therapeutic effect score divided by Side effects score, so efficacy index varies from 0.25 to 4 (higher is better).
Time frame: On 90th day of the treatment period.
Population: The number of completed cases (non-missing data) is indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | Therapeutic and Side Effects, Efficacy Index. | Therapeutic effect | 3.3 score on a scale | Standard Deviation 0.6 |
| MMH-MAP | Therapeutic and Side Effects, Efficacy Index. | Side effects | 1.2 score on a scale | Standard Deviation 0.4 |
| MMH-MAP | Therapeutic and Side Effects, Efficacy Index. | Efficiency index | 3.0 score on a scale | Standard Deviation 0.8 |
| Placebo | Therapeutic and Side Effects, Efficacy Index. | Side effects | 1.2 score on a scale | Standard Deviation 0.5 |
| Placebo | Therapeutic and Side Effects, Efficacy Index. | Efficiency index | 2.8 score on a scale | Standard Deviation 0.9 |
| Placebo | Therapeutic and Side Effects, Efficacy Index. | Therapeutic effect | 3.1 score on a scale | Standard Deviation 0.7 |
Comparison: Therapeutic effect score comparison on 90th day of treatment.p-value: 0.067Wilcoxon (Mann-Whitney)
Comparison: Side effects score comparison on 90th day of treatment.p-value: 0.81Wilcoxon (Mann-Whitney)
Comparison: Efficacy index score comparison on 90th day of treatment.p-value: 0.17Wilcoxon (Mann-Whitney)