Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-04 @ 11:58 PM
Study NCT ID:
NCT02847494
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2016-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Corticosteroids for Acute Migraine in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'befriedm@montefiore.org', 'phone': '17189206626', 'title': 'Benjamin W. Friedman, MD', 'organization': 'Montefiore Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 week', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Metoclopramide 10mg IV+ dexamethasone 10mg IM\n\nmetoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes\n\nDexamethasone: dexamethasone 10mg intramuscular injection', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 3, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental', 'description': 'Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM\n\nmetoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes\n\nmethylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 16, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Headache Days as Self-reported by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Metoclopramide 10mg IV+ dexamethasone 10mg IM\n\nmetoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes\n\nDexamethasone: dexamethasone 10mg intramuscular injection'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM\n\nmetoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes\n\nmethylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '3.5'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '3.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days after discharge from emergency department', 'description': 'At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Sustained Headache Freedom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Metoclopramide 10mg IV+ dexamethasone 10mg IM\n\nmetoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes\n\nDexamethasone: dexamethasone 10mg intramuscular injection'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM\n\nmetoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes\n\nmethylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days after discharge from emergency department', 'description': 'Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medication Preference as Assessed by Self-report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Metoclopramide 10mg IV+ dexamethasone 10mg IM\n\nmetoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes\n\nDexamethasone: dexamethasone 10mg intramuscular injection'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM\n\nmetoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes\n\nmethylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days after discharge from emergency department', 'description': 'Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded "yes".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Metoclopramide 10mg IV+ dexamethasone 10mg IM\n\nmetoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes\n\nDexamethasone: dexamethasone 10mg intramuscular injection'}, {'id': 'FG001', 'title': 'Experimental', 'description': 'Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM\n\nmetoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes\n\nmethylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Metoclopramide 10mg IV+ dexamethasone 10mg IM\n\nmetoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes\n\nDexamethasone: dexamethasone 10mg intramuscular injection'}, {'id': 'BG001', 'title': 'Experimental', 'description': 'Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM\n\nmetoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes\n\nmethylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36', 'spread': '13', 'groupId': 'BG000'}, {'value': '39', 'spread': '16', 'groupId': 'BG001'}, {'value': '38', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of headache', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '96'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '120'}, {'value': '72', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '96'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'hours', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-22', 'size': 169765, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-12-18T18:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-18', 'studyFirstSubmitDate': '2016-07-25', 'resultsFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-18', 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache Days as Self-reported by Participants', 'timeFrame': '7 days after discharge from emergency department', 'description': 'At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Sustained Headache Freedom', 'timeFrame': '7 days after discharge from emergency department', 'description': 'Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge.'}, {'measure': 'Medication Preference as Assessed by Self-report', 'timeFrame': '7 days after discharge from emergency department', 'description': 'Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded "yes".'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '30449536', 'type': 'DERIVED', 'citation': 'Latev A, Friedman BW, Irizarry E, Solorzano C, Restivo A, Chertoff A, Zias E, Gallagher EJ. A Randomized Trial of a Long-Acting Depot Corticosteroid Versus Dexamethasone to Prevent Headache Recurrence Among Patients With Acute Migraine Who Are Discharged From an Emergency Department. Ann Emerg Med. 2019 Feb;73(2):141-149. doi: 10.1016/j.annemergmed.2018.09.028. Epub 2018 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'This is an emergency department based randomized trial in which we compare two different treatment for migraine headache. The goal is to decrease the number of headache days during the week after ED discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Migraine without aura criteria (International Classification of Headache Disorders 3B )\n* Headache rated as moderate or severe in intensity\n\nExclusion Criteria:\n\n* Concern for secondary cause of headache\n* Contra-indications to investigational medications'}, 'identificationModule': {'nctId': 'NCT02847494', 'briefTitle': 'Corticosteroids for Acute Migraine in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial', 'orgStudyIdInfo': {'id': '2016-6342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Metoclopramide 10mg IV+ dexamethasone 10mg IM', 'interventionNames': ['Drug: metoclopramide', 'Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental', 'description': 'Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM', 'interventionNames': ['Drug: metoclopramide', 'Drug: methylprednisolone acetate']}], 'interventions': [{'name': 'metoclopramide', 'type': 'DRUG', 'description': 'metoclopramide 10mg intravenous infusion over 15 minutes', 'armGroupLabels': ['Control', 'Experimental']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'dexamethasone 10mg intramuscular injection', 'armGroupLabels': ['Control']}, {'name': 'methylprednisolone acetate', 'type': 'DRUG', 'description': 'methylprednislone acetate 160mg intramuscular injection', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center--Einstein', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center-Moses', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Benjamin W Friedman, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Benjamin W. Friedman, MD', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}