Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT01556802
Status:
UNKNOWN
Last Update Posted:
2012-03-16
First Post:
2012-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Minocicline in Patients With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D010243', 'term': 'Paralysis'}], 'ancestors': [{'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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-15', 'studyFirstSubmitDate': '2012-03-05', 'studyFirstSubmitQcDate': '2012-03-15', 'lastUpdatePostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the efficacy of minocycline in reducing neurological sequelae in patients with stroke', 'timeFrame': 'one year', 'description': 'The researchers evaluated the neurological condition of paralysis, aphasia,and level of consciousness by NIHSS score for each patient with stroke and proceeded to give minocycline or placebo. Then, the assessment was repeated after five and thirty days post treatment to determine whether their neurological sequelae had diminushed.'}], 'secondaryOutcomes': [{'measure': 'Identify the side effects of the intervention administered during the treatment time and 30 days later.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stroke', 'sequelaes', 'minocicline'], 'conditions': ['Stroke', 'Brain Ischemia', 'Paralysis']}, 'descriptionModule': {'briefSummary': 'The investigators will evaluate the National Institute of Health Stroke Scale/Score (NIHSS)in patients with stroke, and then give Minocycline 100mg po every 12 hours or placebo for five days, then perform periodic evaluations to determine the status and degree of neurological sequelae developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NIHSS scale greater than 5\n* Onset of symptoms less than 24 hours\n* normal Cranial Tomography(CT)\n* CT evidence of cerebral ischemia\n* Acceptance of study entry\n\nExclusion Criteria:\n\n* Hemorrhagic cerebrovascular disease\n* Other neurological diseases\n* Concomitant structural damage\n* History of neurosurgery\n* Known allergy to tetracyclines\n* Concomitant infectious diseases requiring antibiotic treatment.\n* History of Stroke\n* Women pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT01556802', 'briefTitle': 'Use of Minocicline in Patients With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Hernando Moncaleano Perdomo'}, 'officialTitle': 'Effect of Minocicline Use in Less Neurologic Sequels in Patients With Stroke', 'orgStudyIdInfo': {'id': '38212050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minocicline', 'description': 'minocicline 100mg oral twice a day for 5 days', 'interventionNames': ['Drug: Minocicline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Pills filled with vegetal fiber with similar presentation of the drug. Given one pill oral twice a day for five days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Minocicline', 'type': 'DRUG', 'description': 'Minocicline 100mg oral twice a day for 5 days', 'armGroupLabels': ['Minocicline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pills with vegetable fibers one pill oral twice a day for five days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Neiva', 'state': 'Huila Department', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Nataly Bedoya, Md.', 'role': 'CONTACT', 'email': 'nata0916@hotmail.com'}], 'facility': 'University Hospital hernando Moncaleano Perdomo', 'geoPoint': {'lat': 2.93001, 'lon': -75.27973}}], 'centralContacts': [{'name': 'Nataly Bedoya, md', 'role': 'CONTACT', 'email': 'nata0916@hotmail.com'}], 'overallOfficials': [{'name': 'Nataly Bedoya, Internist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad Surcolombiana'}, {'name': 'Hernan Vargas, Internist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Surcolombiana'}, {'name': 'Hugo Osorio, Internist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Surcolombiana'}, {'name': 'Guillermo Gonzalez, Neurologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Surcolombiana'}, {'name': 'Javier Saldaña, Epidemiology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Surcolombiana'}, {'name': 'Efrain Amaya, Neurologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Hernando Moncaleano Perdomo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Hernando Moncaleano Perdomo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Internist', 'investigatorFullName': 'Nataly Bedoya', 'investigatorAffiliation': 'Hospital Universitario Hernando Moncaleano Perdomo'}}}}