[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100348323":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":28,"responsibleParty":265,"collaborators":25,"id":267,"slug":268,"hasResults":269,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":25,"eligibilityCriteria":273,"healthyVolunteers":274,"sex":275,"minAge":276,"maxAge":277,"enrollmentInfo":278,"targetDuration":25,"studyType":281,"phases":282,"briefSummary":284,"conditions":285,"keywords":25,"overallStatus":288,"whyStopped":25,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},{"fullName":5,"class":6},"Materia Medica Holding","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MMH-MAP","EXPERIMENTAL","Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets\u002Fday). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.",[13],"Drug: MMH-MAP",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo for 24 weeks, according to the MMH-MAP dosing regimen.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Oral administration",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29,41,50,59,65,74,83,92,98,104,113,118,124,133,142,151,157,166,175,184,193,202,211,220,229,238,247,256],{"facility":30,"status":25,"city":31,"state":25,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":25},"Arkhangelsk Regional Clinical Hospital","Arkhangelsk","163045","Russia","RU",{"type":36,"coordinates":37},"Point",[38,39],40.55183,64.5461,{"lat":39,"lon":38},{"facility":42,"status":25,"city":43,"state":25,"zip":44,"country":33,"countryCode":34,"cosmosGeoPoint":45,"geoPoint":49,"contacts":25},"Belgorod Regional Clinical Hospital of St. Joseph","Belgorod","308007",{"type":36,"coordinates":46},[47,48],36.58091,50.60343,{"lat":48,"lon":47},{"facility":51,"status":25,"city":52,"state":25,"zip":53,"country":33,"countryCode":34,"cosmosGeoPoint":54,"geoPoint":58,"contacts":25},"Non-State Healthcare Institution \"Divisional Hospital at the Bryansk-2 station of the open joint-stock company Russian Railways\"","Bryansk","241004",{"type":36,"coordinates":55},[56,57],34.32143,53.27096,{"lat":57,"lon":56},{"facility":60,"status":25,"city":52,"state":25,"zip":61,"country":33,"countryCode":34,"cosmosGeoPoint":62,"geoPoint":64,"contacts":25},"Bryansk Regional Hospital № 1","241033",{"type":36,"coordinates":63},[56,57],{"lat":57,"lon":56},{"facility":66,"status":25,"city":67,"state":25,"zip":68,"country":33,"countryCode":34,"cosmosGeoPoint":69,"geoPoint":73,"contacts":25},"Federal State Budgetary Educational Institution of Higher Education \"Kazan Medical University\" of the Ministry of Healthcare of the Russian Federation","Kazan'","420012",{"type":36,"coordinates":70},[71,72],49.12214,55.78874,{"lat":72,"lon":71},{"facility":75,"status":25,"city":76,"state":25,"zip":77,"country":33,"countryCode":34,"cosmosGeoPoint":78,"geoPoint":82,"contacts":25},"Scientific-Research Institute - Regional Clinical Hospital №1 named after Professor S.V. Ochapovsky","Krasnodar","350086",{"type":36,"coordinates":79},[80,81],38.98178,45.04534,{"lat":81,"lon":80},{"facility":84,"status":25,"city":85,"state":25,"zip":86,"country":33,"countryCode":34,"cosmosGeoPoint":87,"geoPoint":91,"contacts":25},"The State Budget Health Care institution of Moscow the City \"City clinical hospital No. 12 of the Administration of Health Care of Moscow City\"","Moscow","115516",{"type":36,"coordinates":88},[89,90],37.61781,55.75204,{"lat":90,"lon":89},{"facility":93,"status":25,"city":85,"state":25,"zip":94,"country":33,"countryCode":34,"cosmosGeoPoint":95,"geoPoint":97,"contacts":25},"State Budgetary Institution of Healthcare of the City of Moscow City Clinical Hospital No. 1 named after. N.I. Pirogov Moscow Department of Health","119049",{"type":36,"coordinates":96},[89,90],{"lat":90,"lon":89},{"facility":99,"status":25,"city":85,"state":25,"zip":100,"country":33,"countryCode":34,"cosmosGeoPoint":101,"geoPoint":103,"contacts":25},"City Clinical Hospital named after SI. Spasokokukotsky Department of Health of Moscow","127206",{"type":36,"coordinates":102},[89,90],{"lat":90,"lon":89},{"facility":105,"status":25,"city":106,"state":25,"zip":107,"country":33,"countryCode":34,"cosmosGeoPoint":108,"geoPoint":112,"contacts":25},"City Clinical Hospital №5 of Nizhny Novgorod region of Nizhny Novgorod","Nizhny Novgorod","603005",{"type":36,"coordinates":109},[110,111],44.00205,56.32867,{"lat":111,"lon":110},{"facility":114,"status":25,"city":106,"state":25,"zip":107,"country":33,"countryCode":34,"cosmosGeoPoint":115,"geoPoint":117,"contacts":25},"Privolzhskiy Research Medical University",{"type":36,"coordinates":116},[110,111],{"lat":111,"lon":110},{"facility":119,"status":25,"city":106,"state":25,"zip":120,"country":33,"countryCode":34,"cosmosGeoPoint":121,"geoPoint":123,"contacts":25},"State budgetary institution of public health services of the Nizhniy Novgorod region \"Nizhegorod Regional Clinical Hospital named after NA Semashko\"","603126",{"type":36,"coordinates":122},[110,111],{"lat":111,"lon":110},{"facility":125,"status":25,"city":126,"state":25,"zip":127,"country":33,"countryCode":34,"cosmosGeoPoint":128,"geoPoint":132,"contacts":25},"Pyatigorsk City Clinical Hospital № 2","Pyatigorsk","357538",{"type":36,"coordinates":129},[130,131],43.05036,44.05,{"lat":131,"lon":130},{"facility":134,"status":25,"city":135,"state":25,"zip":136,"country":33,"countryCode":34,"cosmosGeoPoint":137,"geoPoint":141,"contacts":25},"Ryazan State Medical University named after academician I.P. Pavlov","Ryazan","390026",{"type":36,"coordinates":138},[139,140],39.70415,54.62696,{"lat":140,"lon":139},{"facility":143,"status":25,"city":144,"state":25,"zip":145,"country":33,"countryCode":34,"cosmosGeoPoint":146,"geoPoint":150,"contacts":25},"St. Petersburg I. I. Dzhanelidze Research Institute of Emergency Medicine","Saint Petersburg","192242",{"type":36,"coordinates":147},[148,149],30.31413,59.93863,{"lat":149,"lon":148},{"facility":152,"status":25,"city":144,"state":25,"zip":153,"country":33,"countryCode":34,"cosmosGeoPoint":154,"geoPoint":156,"contacts":25},"Leningrad Regional Clinical Hospital","194291",{"type":36,"coordinates":155},[148,149],{"lat":149,"lon":148},{"facility":158,"status":25,"city":159,"state":25,"zip":160,"country":33,"countryCode":34,"cosmosGeoPoint":161,"geoPoint":165,"contacts":25},"State budgetary institution of health care of the Samara region \"Samara City Clinical Hospital № 1 named after NI Pirogov\"","Samara","443096",{"type":36,"coordinates":162},[163,164],50.13553,53.20767,{"lat":164,"lon":163},{"facility":167,"status":25,"city":168,"state":25,"zip":169,"country":33,"countryCode":34,"cosmosGeoPoint":170,"geoPoint":174,"contacts":25},"Republican Clinical Hospital №4","Saransk","430032",{"type":36,"coordinates":171},[172,173],45.17166,54.18485,{"lat":173,"lon":172},{"facility":176,"status":25,"city":177,"state":25,"zip":178,"country":33,"countryCode":34,"cosmosGeoPoint":179,"geoPoint":183,"contacts":25},"Saratov State Medical University named after V. I. Razumovsky","Saratov","410012",{"type":36,"coordinates":180},[181,182],45.9901,51.54048,{"lat":182,"lon":181},{"facility":185,"status":25,"city":186,"state":25,"zip":187,"country":33,"countryCode":34,"cosmosGeoPoint":188,"geoPoint":192,"contacts":25},"St. Petersburg State Budgetary Institution \"City Hospital No. 40 in the Kurortny District\"","Sestroretsk","197706",{"type":36,"coordinates":189},[190,191],29.96378,60.09801,{"lat":191,"lon":190},{"facility":194,"status":25,"city":195,"state":25,"zip":196,"country":33,"countryCode":34,"cosmosGeoPoint":197,"geoPoint":201,"contacts":25},"Smolensk State Medical University","Smolensk","214018",{"type":36,"coordinates":198},[199,200],32.05088,54.77826,{"lat":200,"lon":199},{"facility":203,"status":25,"city":204,"state":25,"zip":205,"country":33,"countryCode":34,"cosmosGeoPoint":206,"geoPoint":210,"contacts":25},"State budgetary institution of health care of the Tver region \"Regional Clinical Treatment and Rehabilitation Center\"","Tver'","170026",{"type":36,"coordinates":207},[208,209],35.90057,56.85836,{"lat":209,"lon":208},{"facility":212,"status":25,"city":213,"state":25,"zip":214,"country":33,"countryCode":34,"cosmosGeoPoint":215,"geoPoint":219,"contacts":25},"State Healthcare Institution Ulyanovsk Regional Clinical Hospital","Ulyanovsk","432063",{"type":36,"coordinates":216},[217,218],48.38657,54.32824,{"lat":218,"lon":217},{"facility":221,"status":25,"city":222,"state":25,"zip":223,"country":33,"countryCode":34,"cosmosGeoPoint":224,"geoPoint":228,"contacts":25},"State budgetary health care institution of the Vladimir region \"Regional Clinical Hospital\"","Vladimir","600023",{"type":36,"coordinates":225},[226,227],40.39976,56.13854,{"lat":227,"lon":226},{"facility":230,"status":25,"city":231,"state":25,"zip":232,"country":33,"countryCode":34,"cosmosGeoPoint":233,"geoPoint":237,"contacts":25},"Volgograd State Medical University","Volgograd","400131",{"type":36,"coordinates":234},[235,236],44.4976,48.71378,{"lat":236,"lon":235},{"facility":239,"status":25,"city":240,"state":25,"zip":241,"country":33,"countryCode":34,"cosmosGeoPoint":242,"geoPoint":246,"contacts":25},"Voronezh Regional Clinical Hospital № 1","Voronezh","394066",{"type":36,"coordinates":243},[244,245],39.19204,51.66833,{"lat":245,"lon":244},{"facility":248,"status":25,"city":249,"state":25,"zip":250,"country":33,"countryCode":34,"cosmosGeoPoint":251,"geoPoint":255,"contacts":25},"Vsevolozhsk Clinical Interdistrict Hospital","Vsevolozhsk","188643",{"type":36,"coordinates":252},[253,254],30.67314,60.01512,{"lat":254,"lon":253},{"facility":257,"status":25,"city":258,"state":25,"zip":259,"country":33,"countryCode":34,"cosmosGeoPoint":260,"geoPoint":264,"contacts":25},"State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8","Yaroslavl","150030",{"type":36,"coordinates":261},[262,263],39.87368,57.62987,{"lat":263,"lon":262},{"type":266,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100348323","phase-3-clinical-trial-of-efficacy-and-safety-of-mmh-map-in-the-treatment-of-mild-cognitive-impairment-in-early-recovery-stage-after-ischemic-stroke-100348323",true,"NCT03815292","Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Early Recovery Stage After Ischemic Stroke","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","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 \\\u003C 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\u002Fparenchymatous\u002Fventricular 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\u002For 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\u002Fsuspicion 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\u002Fintolerant 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).",false,"ALL","45 Years","80 Years",{"count":279,"type":280},276,"ACTUAL","INTERVENTIONAL",[283],"PHASE3","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",[286,287],"Mild Cognitive Impairment","Ischemic Stroke","COMPLETED","2021-02-05",{"date":291,"type":280},"2021-02-23",{"date":293,"type":280},"2018-10-19",{"date":295,"type":280},"2020-01-27",{"name":5,"class":6},28]