Phase 3
N=245
Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Cognitive Disorders
Cognitive Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04295681 ↗Enrolled (actual)
245
Serious AEs
3.3%
Results posted
Oct 2024
Primary outcome: Primary: Average MoCA Score. — 20.7; 21.7; 24.6; 24.5 score on a scale — p=0.0006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MMH-MAP (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Materia Medica Holding
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average MoCA Score. |
20.7; 21.7; 24.6; 24.5; 3.9; 2.9 | 0.0006 sig |
| SECONDARY Changes in NIHSS Score. |
8.6; 8.5; 4.9; 4.8; 3.0; 2.9 | 0.67 |
| SECONDARY Percentage of Patients With no Significant Disabilities. |
57; 53 | 0.89 |
| SECONDARY Therapeutic and Side Effects, Efficacy Index. |
3.3; 3.1; 1.2; 1.2; 3.0; 2.8 | 0.067 |
| SECONDARY Presence of Adverse Events (AEs). |
32; 28 | 0.656 |
| SECONDARY Percentage of Patients With Complication of Cerebral Infarction. |
2; 2 | 1 |
| SECONDARY Death Rate. |
0; 0 | — |
| SECONDARY Changes in Vital Signs (Pulse Rate (Heart Rate)). |
74.0; 73.5; 71.3; 71.3; 72.3; 71.4 | 0.96 |
| SECONDARY Changes in Vital Signs (Respiration Rate (Breathing Rate)). |
16.8; 16.8; 16.7; 16.7; 16.8; 16.8 | 0.96 |
| SECONDARY Changes in Vital Signs (Blood Pressure). |
139; 139.0; 129; 130; 129; 130 | 0.438 |
| SECONDARY Percentage of Patients With Clinically Significant Abnormal Laboratory Data. |
19; 16; 2; 1 | 0.72 |
| SECONDARY Percentage of Patients With Recurring Cerebral Infarction. |
2; 1 | 1 |
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.
Eligibility Criteria
Inclusion Criteria
- Age between 40 and 75 years old inclusively.
- Ischemic stroke in the carotid arteries (I 63) within 72 hours post debut.
- Moderate cognitive disorders (MoCA < 26).
- Normal consciousness (Glasgow score 15)
- Stroke severity 8-12 according to NIHSS.
- Disability mRs score 2-3.
- Availability of cerebral CT/MRI within 72 hours post stroke debut.
- Patients who agreed to use a reliable method of contraception during the study.
- Patients who have signed the Participant Information Sheet and Informed Consent.
Exclusion Criteria
- Current or previous subarachnoidal/parenchymatous/ventricular hemorrhage, cerebral infarction, cerebral tumour.
- Cerebral CT/MRI findings suggesting cerebral hemorrhage, tumour within 72 hours post stroke debut.
- Scheduled or completed thrombolytic therapy for the treatment of the current cerebral infarction.
- 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).
- Head injuries (S00-S09) (including history), accompanied by impaired consciousness, brain contusion or open craniocerebral injuries.
- Musculoskeletal disorders causing motor disturbances.
- Dementia (including history) (F00-F03).
- Malignant neoplasms.
- Patients previously diagnosed with class IV heart failure (1964 New York Heart Association functional classification), hypothyroidism, or poorly treated diabetes mellitus.
- Patients having unstable angina or myocardial infarction in the past 6 months.
- Allergy/ intolerance to any of the components of medications used in the treatment.
- Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency) and galactosemia.
- Any conditions which, according to the investigator opinion, may interfere with the subject's participation in the study.
- 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.
- Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
- Participation in other clinical studies within 3 month prior to enrollment in the study.
- 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).
- 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).
Data sourced from ClinicalTrials.gov (NCT04295681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.