Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Cognitive Disorders in Patients With Ischemic Stroke in the Carotid Arteries

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Materia Medica Holding

Criteria

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. (History of) injuries to the head (S00-S09) associated with impaired consciousness, cerebral contusion or open craniocerebral trauma.

6. Musculoskeletal disorders causing motor disturbances.

7. (History of) dementia (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).