Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Cognitive Disorders in Patients With Ischemic Stroke in the Carotid Arteries
Condition: Cognitive Disorders
MeSH terms: Ischemic Stroke; Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 3

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".
    

Intervention name(s): MMH-MAP; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration.; Oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment