Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Cognitive Disorders

Last updated: August 12, 2024
Sponsor: Materia Medica Holding
Overall Status: Completed

Phase

3

Condition

Blood Clots

Memory Problems

Stroke

Treatment

MMH-MAP

Placebo

Clinical Study ID

NCT04295681
MMH-MAP-002
  • Ages 40-75
  • All Genders

Study 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

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

Exclusion Criteria:

  1. Current or previous subarachnoidal/parenchymatous/ventricular hemorrhage, cerebralinfarction, cerebral tumour.

  2. Cerebral CT/MRI findings suggesting cerebral hemorrhage, tumour within 72 hours poststroke debut.

  3. Scheduled or completed thrombolytic therapy for the treatment of the currentcerebral 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).

  1. Head injuries (S00-S09) (including history), accompanied by impaired consciousness,brain contusion or open craniocerebral injuries.

  2. Musculoskeletal disorders causing motor disturbances.

  3. Dementia (including history) (F00-F03).

  4. Malignant neoplasms.

  5. Patients previously diagnosed with class IV heart failure (1964 New York HeartAssociation functional classification), hypothyroidism, or poorly treated diabetesmellitus.

  6. Patients having unstable angina or myocardial infarction in the past 6 months.

  7. Allergy/ intolerance to any of the components of medications used in the treatment.

  8. Malabsorption syndrome, including congenital or acquired lactase deficiency (or anyother disaccharidase deficiency) and galactosemia.

  9. Any conditions which, according to the investigator opinion, may interfere with thesubject's participation in the study.

  10. Prior history of non-adherence to a drug regimen, a psychiatric disorder, alcoholismor drug abuse, which, in the opinion of the investigator, can compromise compliancewith study protocol.

  11. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion inthe trial, unwillingness to use contraceptive methods during the trial.

  12. Participation in other clinical studies within 3 month prior to enrollment in thestudy.

  13. Patients who are related to any of the on-site research personnel directly involvedin 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).

  14. Patients who work for OOO "NPF "Materia Medica Holding" (i.e. the company'semployees, temporary contract workers, designated officials responsible for carryingout the research or any immediate relatives of the aforementioned).

Study Design

Total Participants: 246
Treatment Group(s): 2
Primary Treatment: MMH-MAP
Phase: 3
Study Start date:
December 12, 2019
Estimated Completion Date:
February 07, 2023

Study 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".

Connect with a study center

  • Arkhangelsk Regional Clinical Hospital/Neurological Department

    Arkhangelsk, 163045
    Russian Federation

    Site Not Available

  • The First City Clinical Hospital named after E.E. Volosevich

    Arkhangelsk, 163001
    Russian Federation

    Site Not Available

  • Belgorod Regional Clinical Hospital of St. Joasaph

    Belgorod, 308007
    Russian Federation

    Site Not Available

  • Regional Clinical Hospital # 3

    Chelyabinsk, 454021
    Russian Federation

    Site Not Available

  • City Clinical Hospital # 7

    Kazan, 420103
    Russian Federation

    Site Not Available

  • Interregional Clinical Diagnostic Center

    Kazan, 420101
    Russian Federation

    Site Not Available

  • Kazan State Medical University/Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan

    Kazan, 420012
    Russian Federation

    Site Not Available

  • Research Institute - Regional Clinical Hospital # 1 named after Prof. S.V. Ochapovsky

    Krasnodar, 350086
    Russian Federation

    Site Not Available

  • Central Clinical Hospital of the Russian Academy of Sciences

    Moscow, 117593
    Russian Federation

    Site Not Available

  • City Clinical Hospital named after V.M. Buyanov, Moscow Department of Health

    Moscow, 115516
    Russian Federation

    Site Not Available

  • City Clinical Hospital # 5 of the Nizhegorodskiy District of Nizhny Novgorod

    Nizhny Novgorod, 603005
    Russian Federation

    Site Not Available

  • Novosibirsk State Regional Clinical Hospital

    Novosibirsk, 630087
    Russian Federation

    Site Not Available

  • Regional Clinic Hospital/Emergency cardiology unit with intensive care and resuscitation unit

    Ryazan, 390039
    Russian Federation

    Site Not Available

  • City Multidisciplinary Hospital # 2

    Saint Petersburg, 194354
    Russian Federation

    Site Not Available

  • St. Petersburg Research Institute of Ambulance named after I.I. Janelidze

    Saint Petersburg, 192242
    Russian Federation

    Site Not Available

  • Samara City Clinical Hospital # 1 named after N.I. Pirogov/Neurological Department

    Samara, 443096
    Russian Federation

    Site Not Available

  • Saratov City Clinical Hospital # 9

    Saratov, 410031
    Russian Federation

    Site Not Available

  • Ulyanovsk Regional Clinical Hospital/Neurological Department

    Ulyanovsk, 432063
    Russian Federation

    Site Not Available

  • Regional Clinic Hospital/Neurological department for patients with acute cerebrovascular accident

    Vladimir, 600023
    Russian Federation

    Site Not Available

  • Volgograd State Medical University/Department of Neurology, Neurosurgery with a course in medical genetics

    Volgograd, 400131
    Russian Federation

    Site Not Available

  • Voronezh Regional Clinical Hospital # 1

    Voronezh, 394066
    Russian Federation

    Site Not Available

  • Vsevolozhsk Clinical Interdistrict Hospital

    Vsevolozhsk, 188643
    Russian Federation

    Site Not Available

  • Clinical Hospital # 8/Intensive Care Unit

    Yaroslavl, 150030
    Russian Federation

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.