Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT01388127
Status:
UNKNOWN
Last Update Posted:
2011-07-06
First Post:
2011-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minocycline Treatment in Acute Hemorrhagic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-05', 'studyFirstSubmitDate': '2011-07-03', 'studyFirstSubmitQcDate': '2011-07-05', 'lastUpdatePostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Poor Performance Status']}, 'descriptionModule': {'briefSummary': 'The investigators will perform a double blind controlled study to investigate the efficacy of oral administration of 200 mg minocycline, on the neurological and functional outcome after acute hemorrhagic stroke and the effect on blood brain barrier permeability.', 'detailedDescription': "Minocycline, a semisynthetic second generation derivative of tetracycline, was shown to have a clear beneficial neuroprotective effect in animal models of multiple sclerosis, Parkinson's disease, Huntington's disease and amyotrophic lateral sclerosis. Animal models provide promising evidence of minocycline's ability to improve outcomes in an animal stroke model.\n\nIn light of these findings, we will perform a double blind controlled study to investigate the efficacy of oral administration of 200 mg minocycline, on the neurological and functional outcome after acute hemorrhagic stroke and the effect on blood brain barrier permeability."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '150 patients after acute hemorrhagic stroke. Half treated with Minocycline.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute hemorrhagic stroke\n\n 1. age \\> 18\n 2. NIHSS score \\> 5\n 3. onset of stroke 6 to 24 hours prior to beginning of treatment. Patients, who arrived within 0 to 6 hours post stroke, were treated with other medications according to the best accepted medical treatment guidelines.\n\nExclusion Criteria:\n\n1. Evidence of other disease of the central nervous system, including brain tumor, demyelinating disease, inflammatory disease of the central nervous system, craniotomy in the past, severe brain injuries and benign intracranial hypertension\n2. pre-existing neurological disability\n3. known allergic response to tetracyclines\n4. acute or chronic renal failure\n5. pre-existing infectious disease requiring antibiotic therapy\n6. swallowing difficulties'}, 'identificationModule': {'nctId': 'NCT01388127', 'acronym': 'Minocycline', 'briefTitle': 'Minocycline Treatment in Acute Hemorrhagic Stroke', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'Minocycline Treatment in Acute Hemorrhagic Stroke for Evaluation of Treatment Efficacy and Blood Brain Barrier Permeability', 'orgStudyIdInfo': {'id': '0048-11 WOMC'}}, 'contactsLocationsModule': {'locations': [{'zip': '58100', 'city': 'Holon', 'state': 'Israel', 'country': 'Israel', 'contacts': [{'name': 'Yair Lampl, MD', 'role': 'CONTACT', 'email': 'y_lampl@hotmail.com', 'phone': '972-3-5028512', 'phoneExt': '8512'}, {'name': 'Yair Lampl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Edith Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'overallOfficials': [{'name': 'Yair Lampl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edith Wolfson Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Yair Lampl MD', 'oldOrganization': 'Wolfson Medical Center'}}}}