Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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". ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04295681
Study type Interventional
Source Materia Medica Holding
Contact
Status Completed
Phase Phase 3
Start date December 12, 2019
Completion date February 7, 2023

See also
  Status Clinical Trial Phase
Completed NCT02554253 - The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction Phase 2
Recruiting NCT02777060 - Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures N/A
Completed NCT02342041 - A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects Phase 1
Recruiting NCT01659593 - Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients N/A
Completed NCT01561820 - Mild Cognitive Impairment, Buddy Supported Exercise/ My Buddy Study N/A
Completed NCT00743405 - Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects Phase 1
Completed NCT05373394 - Evaluation of Cognitive and Motor Neurological Disorders in the Short and Long Term After Surgery for the Removal of a Diffuse Low-grade Glioma of the Supplementary Motor Area
Completed NCT04860414 - Prospective Monocentric Study of Taste in Patients With Minor or Major Cognitive Disorders Such as Alzheimer's, Through the Analysis of Gustatory Evoked Potentials. N/A
Completed NCT02324153 - Ramelteon in the Prevention of Post-operative Delirium Phase 2
Completed NCT00458094 - Peer Support for Increasing Physical Activity in People With Serious Mental Illnesses N/A
Completed NCT05486195 - A Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects Including an Assessment of Receptor Occupancy and Food Effect Phase 1
Not yet recruiting NCT03866018 - Contribution of Physical Activity to Self-esteem and Motivation in Older Adults With Minor to Major Cognitive Disorders Such as Alzheimer's Disease or Related Disorders N/A
Recruiting NCT02876536 - Effect of Transcutaneous Electrical Nerve Stimulation on Cognition in Multiple Sclerosis Patients N/A
Completed NCT02321475 - EGb 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders
Completed NCT01881646 - Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery Phase 4
Recruiting NCT05888961 - Single-center Prospective Longitudinal Study of Taste in Patients With Cognitive Disorders at Different Stages of Severity (Isolated Cognitive Complaint, Minor or Major Neurocognitive Alzheimer-type Disorders) by Analysis of Gustatory Evoked Potentials N/A
Completed NCT02575482 - A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy Subjects Phase 1
Completed NCT01983384 - Anesthetic Depth and Postoperative Delirium Trial - 2 N/A
Completed NCT00937846 - Brain Uptake of GSK1034702: a Positron Emission Tomography (PET) Scan Study Phase 1
Completed NCT01772095 - ADVANCE Study: Alzheimer Disease eVAluation iN Clinical PracticE N/A