Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-07 @ 5:04 PM
Study NCT ID:
NCT03040128
Status:
COMPLETED
Last Update Posted:
2017-02-02
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Minocycline in Intracerebral Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-06-04', 'releaseDate': '2018-05-03'}], 'estimatedResultsFirstSubmitDate': '2018-05-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'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'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008911', 'term': 'Minocycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'random number generator (placebo vs. study drug)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-27', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with Treatment-related Adverse Effects', 'timeFrame': 'day 90', 'description': 'Treatment-related adverse effects as noted by package insert: fever, nausea, vomiting, C-diff, hepatic toxicity, dermatitis, anaphylaxis, renal injury)'}], 'secondaryOutcomes': [{'measure': 'Volume (ml) of Perihematomal Edema', 'timeFrame': 'Change from baseline perihematomal edema volume to chronic (day 5-11) perihematomal edema volume', 'description': 'Volumetric analysis (ml) computed from computed tomography head'}, {'measure': 'modified Rankin score', 'timeFrame': 'day 90', 'description': 'modified Rankin score (points ranging from 0 to 6)'}, {'measure': 'Barthel Index', 'timeFrame': 'day 90', 'description': 'Barthel Index score (points ranging from 0 to 100)'}, {'measure': 'National Institutes of Health Stroke Scale Score', 'timeFrame': 'day 90', 'description': 'National Institutes of Health Stroke Scale Score (points ranging from 0 to 42)'}, {'measure': 'Glasgow Coma Score', 'timeFrame': 'day 90', 'description': 'Glasgow Coma Score (points ranging from 3 to 15)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracerebral Hemorrhage']}, 'descriptionModule': {'briefSummary': 'To date, no neuroprotective drugs have demonstrated clinical efficacy in intracerebral hemorrhage (ICH). This study will use intravenous (IV) minocycline in ICH to evaluate for (1) safety/ tolerability and (2) evaluate for clinical efficacy', 'detailedDescription': "Intracerebral hemorrhage (ICH) remains a devastating neurological disorder with high mortality and poor prognosis with unchanged mortality rates (53-59%). Acute treatment options for ICH remain supportive with no available effective drug or surgical therapy. All trials so far have failed to improve clinical outcome in randomized, double-blinded trials. However, one area of interest has been maintaining the integrity of the blood-brain-barrier (BBB) and preventing the growth of vasogenic edema. Matrix metalloproteinases (MMP) are a family of ubiquitous zinc-dependent endopeptidase enzymes whose primary function is the digestion of collagen type IV, laminin, and fibronectin for the purpose of remodeling extracellular basal lamina. Elevated MMP-9 as a pathological process associated with larger hematoma volume, larger perihematomal edema, and poorer clinical outcome in intracerebral hemorrhage is well documented in animal models and patients. One particular MMP-9 inhibitor gaining usage in cerebrovascular disease is minocycline. Normally FDA-approved for bacterial infection and acne vulgaris, minocycline has also been found to be both a safe and effective treatment in ischemic stroke; its potential role as a neuroprotectant in ischemic stroke is currently being tested in a large, randomized, double-blinded trial. Minocycline's beneficial role as a neuroprotectant may also extend to ICH. By inhibiting MMP-9, minocycline may decrease BBB permeability, resulting in less perihematomal edema and decreased mass effect. Although numerous animal ICH models support minocycline's role as an inhibitor of MMP-9 and neuroprotectant, its use has never been studied in humans with ICH."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Age 18-80 yo\n2. Acute neurological deficit with corresponding ICH noted on head CT\n3. Glasgow Coma Scale (GCS) \\> 8\n4. Onset of symptoms within 12 hrs\n5. \\< 30 ml of blood noted on initial CTH (30 ml hematoma volume is a noted independent marker between good and poor clinical outcome)\n6. ICH score \\< 3\n7. English/ Spanish speaking\n\nExclusion Criteria:\n\n1. Allergy to tetracycline and tetracycline analogues\n2. Pregnancy or suspected pregnancy\n3. Hepatic and/or renal insufficiency (LFTs 3x greater than upper limit of normal; creatinine \\> 2 mg/dL)\n4. Thrombocytopenia (plt count \\< 75,000)\n5. History of intolerance to minocycline\n6. Baseline modified Rankin score \\> 1\n7. Stuporous or comatose (GCS \\< 8)\n8. Presence of concomitant serious illness that would confound study, including serious psychiatric disease or prior suicide attempts.'}, 'identificationModule': {'nctId': 'NCT03040128', 'briefTitle': 'Use of Minocycline in Intracerebral Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Minocycline and Matrix Metalloproteinase Inhibition in Acute Intracerebral Hemorrhage: A Pilot Trial', 'orgStudyIdInfo': {'id': 'MITCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'normal saline infusion', 'interventionNames': ['Other: normal saline infusion']}, {'type': 'EXPERIMENTAL', 'label': 'minocycline', 'description': 'intravenous minocycline', 'interventionNames': ['Drug: Minocycline']}], 'interventions': [{'name': 'Minocycline', 'type': 'DRUG', 'description': 'high-dose, intravenous minocycline', 'armGroupLabels': ['minocycline']}, {'name': 'normal saline infusion', 'type': 'OTHER', 'armGroupLabels': ['placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern California', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jason Chang', 'investigatorAffiliation': 'University of Tennessee'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-05-03', 'type': 'RELEASE'}, {'date': '2018-06-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Tennessee'}}}}