Nctid:
NCT06221826
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000020521", "term"=>"Stroke"}, {"id"=>"D000083242", "term"=>"Ischemic Stroke"}], "ancestors"=>[{"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M5207", "name"=>"Brain Injuries", "relevance"=>"LOW"}, {"id"=>"M628", "name"=>"Brain Injuries, Traumatic", "relevance"=>"LOW"}, {"id"=>"M22306", "name"=>"Stroke", "asFound"=>"Stroke, Acute", "relevance"=>"HIGH"}, {"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M2400", "name"=>"Ischemic Stroke", "asFound"=>"Ischemic Stroke", "relevance"=>"HIGH"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C000070020", "term"=>"Emoxypine succinate"}], "ancestors"=>[{"id"=>"D000000975", "term"=>"Antioxidants"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000020011", "term"=>"Protective Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000010975", "term"=>"Platelet Aggregation Inhibitors"}, {"id"=>"D000011619", "term"=>"Psychotropic Drugs"}], "browseLeaves"=>[{"id"=>"M249938", "name"=>"Emoxypine succinate", "asFound"=>"Continuous ECG monitoring", "relevance"=>"HIGH"}, {"id"=>"M4029", "name"=>"Central Nervous System Stimulants", "relevance"=>"LOW"}, {"id"=>"M4292", "name"=>"Antioxidants", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M13865", "name"=>"Platelet Aggregation Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"Platelet Aggregation Inhibitors", "abbrev"=>"PlAggInh"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Stimulants", "abbrev"=>"CNSSti"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>60}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-04-17", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2023-09-12", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-05-29", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-06-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-09-12", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Аssessment of attentiveness and performance", "timeFrame"=>"66 days", "description"=>"Schulte test: assessment of test time before starting therapy, at the end of the parenteral therapy phase and at the end of the course of therapy"}, {"measure"=>"Dynamics of cognitive status", "timeFrame"=>"66 days", "description"=>"The Montreal Cognitive Assessment (MoCA test) \\[31 point scale: min value 0, max value 30, higher scores mean a better outcome\\]"}, {"measure"=>"Severity of depression", "timeFrame"=>"66 days", "description"=>"The Beck Depression Inventory (BDI scale) \\[64 point scale: min value 0, max value 63, higher scores mean a worse outcome\\]"}, {"measure"=>"Reduction in anxiety", "timeFrame"=>"66 days", "description"=>"The Hospital Anxiety and Depression Scale (HADS) \\[43 point scale: min value 0, max value 42, higher scores mean a worse outcome\\]"}, {"measure"=>"Severity of Post Intensive Care Syndrome", "timeFrame"=>"66 days", "description"=>"The Post Intensive Care Syndrome (PICS) score \\[21 point scale: min value 0, max value 10 with 0,5 point scale division, higher scores mean a worse outcome\\]"}, {"measure"=>"Dynamics of level of mobility", "timeFrame"=>"66 days", "description"=>"The Rivermead index \\[16 point scale: min value 0, max value 15, higher scores mean a better outcome\\]"}, {"measure"=>"Dynamics of neurophysiological parameters (EEG, TCDG) at the time of the Schulte test", "timeFrame"=>"The time of the first infusion of Mexidol", "description"=>"Comparison of electroencephalogram (EEG) and transcranial dopplerography (TCDG) parameters (systolic cerebral blood flow velocity and overshoot coefficient) in the main group (during the Mexidol infusion) and in the control group (no infusion) \\[event related monitoring\\]"}], "secondaryOutcomes"=>[{"measure"=>"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]", "timeFrame"=>"66 days", "description"=>"Adverse events related to Mexidol"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Ischemic Stroke", "Acute Stroke", "Cerebral stroke", "Traumatic Brain Injury", "Acute Cerebrovascular Accident", "ACVA", "Acute cerebral failure", "Neuroprotection", "Mexidol", "Ethylmethylhydroxypyridine Succinate"], "conditions"=>["Ischemic Stroke, Acute"]}, "descriptionModule"=>{"briefSummary"=>"The use of metabolic modulators creates prospects for increasing the efficiency of the rehabilitation treatment of patients with acute cerebral failure", "detailedDescription"=>"Modern neurorehabilitation is a set of basic and adjuvant treatment methods that provide a modulating effect on the neurorestoration process. The range of basic rehabilitation practices includes kinesiotherapy, occupational therapy, speech therapy, and neuropsychology. Adjuvant methods include physiotherapeutic and medicinal methods. For this study, the investigators chose MEXIDOL® as an adjuvant metabolic medicine, which has the ability to modulate receptor complexes of brain membranes, in particular benzodiazepine, GABA, acetylcholine, enhancing their ability to bind to specific ligands. This pharmacodynamic feature of the drug can have a positive effect on the psycho-emotional state of patients, which in turn will increase motivation and, consequently, the success of the rehabilitation process"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Acute Ischemic Stroke\n* Montreal Cognitive Assessment (MoCA) test \\>15; ≤22\n\nExclusion Criteria:\n\n* Under 18 years old\n* Epilepsy\n* Pregnancy\n* Acute failure of one or more organ systems\n* Purulent-inflammatory disease of any localization\n* Participating in any other clinical trial"}, "identificationModule"=>{"nctId"=>"NCT06221826", "briefTitle"=>"MEXIDOL® in the Rehabilitation Treatment of Patients With Acute Cerebral Failure", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Pharmasoft"}, "officialTitle"=>"Prospective Randomized Study of the Modulating Effect of MEXIDOL® as an Adjuvant Stimulant of the Cognitive-emotional Component of the Rehabilitation Treatment in Patients With Acute Cerebral Failure", "orgStudyIdInfo"=>{"id"=>"MexidolNeuro2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Main (Mexidol and standard treatment)", "description"=>"Mexidol IV 500 mg for 10 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks; and standard treatment", "interventionNames"=>["Drug: Mexidol"]}, {"type"=>"NO_INTERVENTION", "label"=>"Control", "description"=>"Standard treatment: basic practices of kinesitherapy, occupational therapy, speech therapy, clinical psychology, supplemented by adjuvant procedures of electrotherapy and rehabilitation environment therapy. The patient's rehabilitation load was at least 3 hours a day for 12 days"}], "interventions"=>[{"name"=>"Mexidol", "type"=>"DRUG", "otherNames"=>["Ethylmethylhydroxypyridine Succinate"], "description"=>"Neurocytoprotector", "armGroupLabels"=>["Main (Mexidol and standard treatment)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"623702", "city"=>"Ekaterinburg", "state"=>"Sverdlovsk Region", "country"=>"Russian Federation", "facility"=>"Brain Institute Clinic", "geoPoint"=>{"lat"=>56.8519, "lon"=>60.6122}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Pharmasoft", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
