Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-03-17 @ 4:19 AM
Study NCT ID:
NCT03815292
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2018-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Early Recovery Stage After Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PutilovskiyMA@materiamedica.ru', 'phone': '+74952761571', 'title': 'Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director', 'phoneExt': '302', 'organization': 'MATERIA MEDICA HOLDING'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During the study - 28 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.\n\nMMH-MAP: Oral administration', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 135, 'otherNumAffected': 37, 'seriousNumAtRisk': 135, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.\n\nPlacebo: Oral administration', 'otherNumAtRisk': 140, 'deathsNumAtRisk': 140, 'otherNumAffected': 39, 'seriousNumAtRisk': 140, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Acute abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in the upper abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral herpes', 'notes': 'Upper lip herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Itchy rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Limb pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cognitive impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Memory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Liver steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Heartbeat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Labile blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercholesterolemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Protein in urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oxalates in urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abnormal urine test results', 'notes': 'Leukocyte esterase, hemoglobin traces, nitrites, leukocytes, erythrocytes, bacteria in a small amount', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increased blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increased liver enzyme levels', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood pressure decrease', 'notes': 'Decrease in blood pressure on an outpatient basis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hunger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Affective lability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increased libido', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Low mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sense of anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hematoma due to trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Limb vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Limb vein thrombosis', 'notes': 'Lower limb vein phlebothrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'notes': 'Deep vein thrombosis of the right leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral infarction', 'notes': 'Recurrent cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nosocomial pneumonia', 'notes': 'Early nosocomial right-sided mid-lobe pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'notes': 'Acute abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertebrobasilar stroke', 'notes': 'Repeated ischemic stroke in the vertebrobasilar basin with infarction in the left cerebellar hemisphere', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Recurrent stroke', 'notes': 'Recurrent cryptogenic ischemic stroke in the vertebrobasilar basin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Improved Cognitive Function (The Montreal Cognitive Assessment Test Total Score of the Baseline +1 or More)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.\n\nMMH-MAP: Oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.\n\nPlacebo: Oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks of the treatment as compared to the baseline', 'description': 'MoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in MoCA (The Montreal Cognitive Assessment Test) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.\n\nMMH-MAP: Oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.\n\nPlacebo: Oral administration'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '19.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '19.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'After 24 weeks', 'categories': [{'measurements': [{'value': '23.3', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': '∆ between baseline and after 24 weeks', 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0445', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to ∆ between baseline and after 24 weeks total scores row.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks of the treatment as compared to the baseline', 'description': 'MoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Patients With Improved Performance in Activities of Daily Living (Barthel Index Score of the Baseline + 5 or More)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.\n\nMMH-MAP: Oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.\n\nPlacebo: Oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0345', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks of the treatment as compared to the baseline', 'description': 'Scale for measurement of performance in activities of daily living (ADL).The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Barthel Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.\n\nMMH-MAP: Oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.\n\nPlacebo: Oral administration'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '74.7', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '74.8', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'After 24 weeks', 'categories': [{'measurements': [{'value': '89.7', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '86.6', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': '∆ between baseline and after 24 weeks', 'categories': [{'measurements': [{'value': '14.9', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '10.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to ∆ between baseline and after 24 weeks total scores row.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks of the treatment as compared to the baseline', 'description': 'Scale for measurement of performance in activities of daily living (ADL).The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.\n\nMMH-MAP: Oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.\n\nPlacebo: Oral administration'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '155.6', 'spread': '33.0', 'groupId': 'OG000'}, {'value': '156.6', 'spread': '32.6', 'groupId': 'OG001'}]}]}, {'title': 'After 24 weeks', 'categories': [{'measurements': [{'value': '184.2', 'spread': '35.3', 'groupId': 'OG000'}, {'value': '173.7', 'spread': '38.0', 'groupId': 'OG001'}]}]}, {'title': '∆ between baseline and after 24 weeks', 'categories': [{'measurements': [{'value': '27.9', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '26.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to ∆ between baseline and after 24 weeks total scores row.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks of the treatment as compared to the baseline', 'description': 'Scale for assessment of health-related quality of life. The scale consists of 49 items in the 12 domains. Each domain consists of 3 to 10 items that are averaged to generate an overall score. Total score minimum value is 1 and maximum value is 245. Higher values represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The CGI-EI (Clinical Global Impression Efficacy Index) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.\n\nMMH-MAP: Oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.\n\nPlacebo: Oral administration'}], 'classes': [{'title': 'Therapeutic effect', 'categories': [{'measurements': [{'value': '5.7', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'Side effects', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Efficacy index', 'categories': [{'measurements': [{'value': '5.8', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0054', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to Therapeutic effect row.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to Side effects row.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0042', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to Efficiency index row.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks of the treatment', 'description': 'Rating scale for assessment of the therapeutic effect of treatment and associated side effects. The scale consists of 2 items: therapeutic effect and side effects. Scores in therapeutic effect range from 1 (marked improvement) to 13 (unchanged or worse). Scores in side effects range from 0 (no side effects) to 3 (side effects outweigh therapeutic effects). Efficacy index ranges between 0 and 16. Higher values represent a worse result.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.\n\nMMH-MAP: Oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.\n\nPlacebo: Oral administration'}], 'classes': [{'title': 'After 24 weeks', 'categories': [{'measurements': [{'value': '23.3', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'After 28 weeks', 'categories': [{'measurements': [{'value': '23.6', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '22.7', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': '∆ between 24 and 28 weeks', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.77', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to ∆ between 24 and 28 weeks total scores row.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 and 28 weeks of the study', 'description': 'Test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Barthel Index Score During Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.\n\nMMH-MAP: Oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.\n\nPlacebo: Oral administration'}], 'classes': [{'title': 'After 24 weeks', 'categories': [{'measurements': [{'value': '89.7', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '86.6', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'After 28 weeks', 'categories': [{'measurements': [{'value': '90.6', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '87.4', 'spread': '10.1', 'groupId': 'OG001'}]}]}, {'title': '∆ between 24 and 28 weeks', 'categories': [{'measurements': [{'value': '1.5', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0118', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to ∆ between 24 and 28 weeks total scores row.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 and 28 weeks of the study', 'description': 'Scale for measurement of performance in activities of daily living (ADL). The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.\n\nMMH-MAP: Oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.\n\nPlacebo: Oral administration'}], 'classes': [{'title': 'After 24 weeks', 'categories': [{'measurements': [{'value': '184.2', 'spread': '35.3', 'groupId': 'OG000'}, {'value': '173.7', 'spread': '38.0', 'groupId': 'OG001'}]}]}, {'title': 'After 28 weeks', 'categories': [{'measurements': [{'value': '187.8', 'spread': '37.7', 'groupId': 'OG000'}, {'value': '174.7', 'spread': '38.0', 'groupId': 'OG001'}]}]}, {'title': '∆ between 24 and 28 weeks', 'categories': [{'measurements': [{'value': '4.1', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '10.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis applies to ∆ between 24 and 28 weeks total scores row.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 and 28 weeks of the study', 'description': 'Scale for assessment of health-related quality of life. The scale consists of 49 items in the 12 domains.Each domain consists of 3 to 10 items that are averaged to generate an overall score.Total score minimum value is 1 and maximum value is 245.Higher values represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.\n\nMMH-MAP: Oral administration'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.\n\nPlacebo: Oral administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In total, 276 patients signed informed consent. After screening procedures, data from 1 patient did not meet the inclusion / exclusion criteria. The study randomized 275 patients.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.\n\nMMH-MAP: Oral administration'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.\n\nPlacebo: Oral administration'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.5', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '63.5', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '64.0', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-29', 'size': 232584, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-14T16:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 276}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-05', 'studyFirstSubmitDate': '2018-11-11', 'resultsFirstSubmitDate': '2020-12-17', 'studyFirstSubmitQcDate': '2019-01-23', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-05', 'studyFirstPostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in MoCA (The Montreal Cognitive Assessment Test) Score', 'timeFrame': '24 weeks of the treatment as compared to the baseline', 'description': 'MoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.'}, {'measure': 'Percentage of Patients With Improved Performance in Activities of Daily Living (Barthel Index Score of the Baseline + 5 or More)', 'timeFrame': '24 weeks of the treatment as compared to the baseline', 'description': 'Scale for measurement of performance in activities of daily living (ADL).The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome.'}, {'measure': 'Change in Barthel Index Score', 'timeFrame': '24 weeks of the treatment as compared to the baseline', 'description': 'Scale for measurement of performance in activities of daily living (ADL).The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome.'}, {'measure': 'Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score', 'timeFrame': '24 weeks of the treatment as compared to the baseline', 'description': 'Scale for assessment of health-related quality of life. The scale consists of 49 items in the 12 domains. Each domain consists of 3 to 10 items that are averaged to generate an overall score. Total score minimum value is 1 and maximum value is 245. Higher values represent a better outcome.'}, {'measure': 'The CGI-EI (Clinical Global Impression Efficacy Index) Score', 'timeFrame': '24 weeks of the treatment', 'description': 'Rating scale for assessment of the therapeutic effect of treatment and associated side effects. The scale consists of 2 items: therapeutic effect and side effects. Scores in therapeutic effect range from 1 (marked improvement) to 13 (unchanged or worse). Scores in side effects range from 0 (no side effects) to 3 (side effects outweigh therapeutic effects). Efficacy index ranges between 0 and 16. Higher values represent a worse result.'}, {'measure': 'Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up', 'timeFrame': '24 and 28 weeks of the study', 'description': 'Test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.'}, {'measure': 'Change in Barthel Index Score During Follow-up', 'timeFrame': '24 and 28 weeks of the study', 'description': 'Scale for measurement of performance in activities of daily living (ADL). The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome.'}, {'measure': 'Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up', 'timeFrame': '24 and 28 weeks of the study', 'description': 'Scale for assessment of health-related quality of life. The scale consists of 49 items in the 12 domains.Each domain consists of 3 to 10 items that are averaged to generate an overall score.Total score minimum value is 1 and maximum value is 245.Higher values represent a better outcome.'}], 'primaryOutcomes': [{'measure': 'Percentage of Patients With Improved Cognitive Function (The Montreal Cognitive Assessment Test Total Score of the Baseline +1 or More)', 'timeFrame': '24 weeks of the treatment as compared to the baseline', 'description': 'MoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', 'Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is:\n\n* to evaluate efficacy of MMH-MAP in the treatment of mild cognitive impairment in subjects in early rehabilitation period of ischemic stroke\n* to evaluate safety of MMH-MAP in the treatment of mild cognitive impairment in subjects in early rehabilitation period of ischemic stroke', 'detailedDescription': 'A double-blind, placebo-controlled randomized clinical trial in parallel groups.\n\nThe study patients are subjects of either gender, aged 45-80 years old, after an ischemic stroke within 3-6 months prior to enrollment and confirmed by neuroimaging, having mild cognitive impairment.\n\nAfter the patients provide signed Participant Information Sheet and Informed Consent, they will be interviewed for complaints and medical history and undergo physical examination and laboratory tests. The doctor will rate the severity of patients\' cognitive impairments on the Mini Mental State Examination (MMSE) scale and Montreal Cognitive Assessment (MoCA) scale, assess their performance in activities of daily living on the Barthel Index scale \\[Collin C, Wade DT, Davies S, Horne V. "The Barthel ADL Index: a reliability study." Int Disability Study.1988;10:61-63.\\], and administer the Stroke Specific Quality of Life Scale (SS-QOL) questionnaire \\[Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke 1999 Jul;30(7):1362-9\\]. Eligible participants will have to have moderate cognitive impairments (MMSE score - at least 21 and MoCA - less than 26). Therapy received by patients for their co-morbidities and primary diagnosis will be recorded. All women of childbearing potential will be administered pregnancy tests.\n\nIf a patient meets all inclusion criteria and does not have any exclusion criteria at Visit 1, he/she is randomized to one of the two groups: group 1 will receive MMH-MAP at 2 tablets twice daily; group 2 will receive Placebo using the study product dosing regimen. The total duration of follow-up and treatment will be 28 weeks, which will include 5 additional visits.\n\nAt Visit 2 (Week 4±7 days), the doctor records patients\' complaints and physical examination data, reviews the progress of study and basic and concomitant therapy, and assesses treatment safety and patient compliance with treatment.\n\nAt Visit 3 (Week 8±7 days), Visit 4 (Week 16±7 days), and Visit 5 (Week 24±7 days), the doctor assesses patients\' cognitive impairments (MoCA) and performance in activities of daily living (the Barthel Index). The patients complete the SS-QOL questionnaire.\n\nAt Visit 5 (Week 24±7 days), the doctor will additionally complete the Clinical Global Impression Efficacy Index (CGI-EI) scale \\[Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976 Rockville, MD, U.S. Department of Health, Education, and Welfare\\] and collect samples for laboratory testing. The patient stops taking the study drug.\n\nAfter four weeks following the end of study therapy patients complete a follow-up visit -Visit 6 (Week 28±7 days). The patients are interviewed for complaints and undergo physical examination, with a check on their concomitant and primary therapies as well as on the safety of study treatment. The doctor assesses patients\' cognitive impairments (MoCA) and performance in activities of daily living (the Barthel Index) and administers the SS-QOL questionnaire.\n\nThe total length of the observation period will be 28 weeks. During the study, symptomatic therapy and therapy for underlying chronic conditions are allowed with the exception of the drugs indicated in the section "Prohibited Concomitant Treatment".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients of either sex, aged 45 to 80 years old inclusively.\n2. Patients with a history of one stroke sustained 3 to 6 months prior to study entry and confirmed by neuroimaging.\n3. Patients with cognitive impairment (MoCA score \\< 26).\n4. Patients with moderate performance in activities of daily living (Barthel score = 61-80).\n5. Agreement to use a reliable method of birth control for the duration of the study (men and women of reproductive potential).\n6. Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.\n\nExclusion Criteria:\n\n1. Patients with a history of subarachnoid/parenchymatous/ventricular hemorrhage, brain neoplasm, or any other condition which has caused neurological dysfunction.\n2. History of central nervous system (CNS) disorders, including:\n\n * inflammatory diseases of the CNS (G00-G09)\n * systemic atrophies primarily affecting the CNS (G10-G13)\n * extrapyramidal and movement disorders (G20-G26)\n * other degenerative diseases of the nervous system (G30-G32)\n * demyelinating diseases of the CNS (G35-G37)\n * epilepsy (G40-41)\n * polyneuropathies and other disorders of the peripheral nervous system (G60-64), with marked movement and/or sensory impairments that cause movement disorders\n * diseases of neuromuscular junction and muscle (G70-73)\n * hydrocephalus (G91)\n * compression of brain (G93.5).\n3. Dementia (20 or less on the MMSE score).\n4. Speech disorders affecting investigator-patient communication.\n5. Prior diagnosis of heart failure defined by the New York Heart Association classification (1964) as IV Functional Classification or poorly treated hypothyroidism or diabetes mellitus.\n6. Patients having unstable angina or myocardial infarction in the past 6 months.\n7. History/suspicion of oncology of any location (except for benign neoplasms).\n8. Any other co-morbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial.\n9. Patients allergic to/intolerant of any components of the study treatment.\n10. Patients with hereditary lactose intolerance.\n11. Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency) and galactosemia.\n12. Pregnancy, breast-feeding or unwillingness to use birth control during the study.\n13. Patients who, from the investigator's point of view, will not comply with the observation requirements of the study or adhere to study drug dosing regimens.\n14. Patients with a history of non-adherence to medication; mental disorder (except for cognitive deficits); or alcoholism or abuse of psychoactive substances, which, in the investigator's opinion, will compromise compliance with study procedures.\n15. Patients who have used medications listed in 'Prohibited Concomitant Treatment' in the past week.\n16. Participation in other clinical trials in the previous 3 months.\n17. 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).\n18. Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned)."}, 'identificationModule': {'nctId': 'NCT03815292', 'briefTitle': 'Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Early Recovery Stage After Ischemic Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Materia Medica Holding'}, 'officialTitle': 'Multicenter Double-blind Placebo-controlled Randomized Parallel-group Clinical Study of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Subjects in Early Rehabilitation Period of Ischemic Stroke', 'orgStudyIdInfo': {'id': 'MMH-MAP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MMH-MAP', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.', 'interventionNames': ['Drug: MMH-MAP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for 24 weeks, according to the MMH-MAP dosing regimen.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MMH-MAP', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['MMH-MAP']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Arkhangelsk Regional Clinical Hospital', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '308007', 'city': 'Belgorod', 'country': 'Russia', 'facility': 'Belgorod Regional Clinical Hospital of St. Joseph', 'geoPoint': {'lat': 50.60343, 'lon': 36.58091}}, {'zip': '241004', 'city': 'Bryansk', 'country': 'Russia', 'facility': 'Non-State Healthcare Institution "Divisional Hospital at the Bryansk-2 station of the open joint-stock company Russian Railways"', 'geoPoint': {'lat': 53.27096, 'lon': 34.32143}}, {'zip': '241033', 'city': 'Bryansk', 'country': 'Russia', 'facility': 'Bryansk Regional Hospital № 1', 'geoPoint': {'lat': 53.27096, 'lon': 34.32143}}, {'zip': '420012', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '350086', 'city': 'Krasnodar', 'country': 'Russia', 'facility': 'Scientific-Research Institute - Regional Clinical Hospital №1 named after Professor S.V. Ochapovsky', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'zip': '115516', 'city': 'Moscow', 'country': 'Russia', 'facility': 'The State Budget Health Care institution of Moscow the City "City clinical hospital No. 12 of the Administration of Health Care of Moscow City"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119049', 'city': 'Moscow', 'country': 'Russia', 'facility': 'State Budgetary Institution of Healthcare of the City of Moscow City Clinical Hospital No. 1 named after. N.I. Pirogov Moscow Department of Health', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '127206', 'city': 'Moscow', 'country': 'Russia', 'facility': 'City Clinical Hospital named after SI. Spasokokukotsky Department of Health of Moscow', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603005', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'City Clinical Hospital №5 of Nizhny Novgorod region of Nizhny Novgorod', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '603005', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Privolzhskiy Research Medical University', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '603126', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'State budgetary institution of public health services of the Nizhniy Novgorod region "Nizhegorod Regional Clinical Hospital named after NA Semashko"', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '357538', 'city': 'Pyatigorsk', 'country': 'Russia', 'facility': 'Pyatigorsk City Clinical Hospital № 2', 'geoPoint': {'lat': 44.05, 'lon': 43.05036}}, {'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'Ryazan State Medical University named after academician I.P. Pavlov', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '192242', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg I. I. Dzhanelidze Research Institute of Emergency Medicine', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194291', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Leningrad Regional Clinical Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443096', 'city': 'Samara', 'country': 'Russia', 'facility': 'State budgetary institution of health care of the Samara region "Samara City Clinical Hospital № 1 named after NI Pirogov"', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '430032', 'city': 'Saransk', 'country': 'Russia', 'facility': 'Republican Clinical Hospital №4', 'geoPoint': {'lat': 54.18485, 'lon': 45.17166}}, {'zip': '410012', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Saratov State Medical University named after V. I. Razumovsky', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '197706', 'city': 'Sestroretsk', 'country': 'Russia', 'facility': 'St. Petersburg State Budgetary Institution "City Hospital No. 40 in the Kurortny District"', 'geoPoint': {'lat': 60.09801, 'lon': 29.96378}}, {'zip': '214018', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Smolensk State Medical University', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '170026', 'city': "Tver'", 'country': 'Russia', 'facility': 'State budgetary institution of health care of the Tver region "Regional Clinical Treatment and Rehabilitation Center"', 'geoPoint': {'lat': 56.85836, 'lon': 35.90057}}, {'zip': '432063', 'city': 'Ulyanovsk', 'country': 'Russia', 'facility': 'State Healthcare Institution Ulyanovsk Regional Clinical Hospital', 'geoPoint': {'lat': 54.32824, 'lon': 48.38657}}, {'zip': '600023', 'city': 'Vladimir', 'country': 'Russia', 'facility': 'State budgetary health care institution of the Vladimir region "Regional Clinical Hospital"', 'geoPoint': {'lat': 56.13854, 'lon': 40.39976}}, {'zip': '400131', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'Volgograd State Medical University', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'zip': '394066', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Voronezh Regional Clinical Hospital № 1', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '188643', 'city': 'Vsevolozhsk', 'country': 'Russia', 'facility': 'Vsevolozhsk Clinical Interdistrict Hospital', 'geoPoint': {'lat': 60.01512, 'lon': 30.67314}}, {'zip': '150030', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Materia Medica Holding', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}