Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-03-04 @ 8:46 PM
Study NCT ID:
NCT03220958
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2017-04-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metoclopramide for Post Traumatic Headache
Sponsor:
Organization:
Raw JSON
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'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': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'befriedm@montefiore.org', 'phone': '718-920-6626', 'title': 'Benjamin Friedman', 'organization': 'Montefiore'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '48 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Metoclopramide', 'description': 'Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip\n\nMetoclopramide: Metoclopramide 20mg\n\nDiphenhydramine: Diphenhydramine 25mg\n\nNormal saline: 100ml normal saline', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 35, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Normal saline, administered as an intravenous drip\n\nNormal saline: 100ml normal saline', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 22, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-concussive syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Various other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoclopramide', 'description': 'Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip\n\nMetoclopramide: Metoclopramide 20mg\n\nDiphenhydramine: Diphenhydramine 25mg\n\nNormal saline: 100ml normal saline'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline, administered as an intravenous drip\n\nNormal saline: 100ml normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour after medication administration', 'description': 'Improvement in this 0 to 10 verbal rating scale', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sustained Headache Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoclopramide', 'description': 'Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip\n\nMetoclopramide: Metoclopramide 20mg\n\nDiphenhydramine: Diphenhydramine 25mg\n\nNormal saline: 100ml normal saline'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline, administered as an intravenous drip\n\nNormal saline: 100ml normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours after medication administration', 'description': 'Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none. Participants rate their headache as none, mild, moderate, or severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoclopramide', 'description': 'Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip\n\nMetoclopramide: Metoclopramide 20mg\n\nDiphenhydramine: Diphenhydramine 25mg\n\nNormal saline: 100ml normal saline'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline, administered as an intravenous drip\n\nNormal saline: 100ml normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days after ED visit', 'description': 'Number of days with any headache. Participants report the actual number of days they experienced headache. A "day" begins when they awake for the beginning of daily activities and ends when they go to sleep after completion of daily activities', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metoclopramide', 'description': 'Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip\n\nMetoclopramide: Metoclopramide 20mg\n\nDiphenhydramine: Diphenhydramine 25mg\n\nNormal saline: 100ml normal saline'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Normal saline, administered as an intravenous drip\n\nNormal saline: 100ml normal saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Metoclopramide', 'description': 'Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip\n\nMetoclopramide: Metoclopramide 20mg\n\nDiphenhydramine: Diphenhydramine 25mg\n\nNormal saline: 100ml normal saline'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Normal saline, administered as an intravenous drip\n\nNormal saline: 100ml normal saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43', 'spread': '16', 'groupId': 'BG000'}, {'value': '46', 'spread': '17', 'groupId': 'BG001'}, {'value': '45', 'spread': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '53', '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': '81', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline pain intensity, as measured on a 0-10 scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '8.3', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-11', 'size': 337372, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-08T12:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-08', 'studyFirstSubmitDate': '2017-04-19', 'resultsFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2017-07-15', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-08', 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable', 'timeFrame': '1 hour after medication administration', 'description': 'Improvement in this 0 to 10 verbal rating scale'}], 'secondaryOutcomes': [{'measure': 'Sustained Headache Relief', 'timeFrame': '48 hours after medication administration', 'description': 'Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none. Participants rate their headache as none, mild, moderate, or severe'}, {'measure': 'Headache Days', 'timeFrame': '7 days after ED visit', 'description': 'Number of days with any headache. Participants report the actual number of days they experienced headache. A "day" begins when they awake for the beginning of daily activities and ends when they go to sleep after completion of daily activities'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Traumatic Headache']}, 'referencesModule': {'references': [{'pmid': '33762421', 'type': 'DERIVED', 'citation': 'Friedman BW, Irizarry E, Cain D, Caradonna A, Minen MT, Solorzano C, Zias E, Zybert D, McGregor M, Bijur PE, Gallagher EJ. Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache. Neurology. 2021 May 4;96(18):e2323-e2331. doi: 10.1212/WNL.0000000000011822. Epub 2021 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'Nearly 1.5 million patients present to US emergency departments annually following head trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of patients with acute post-traumatic headache.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nIncluded patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are as follows:\n\n* Traumatic injury to the head has occurred\n* Headache has developed within 7 days of injury to the head\n* Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)\n\nThe headache must be rated as moderate or severe in intensity at the time of initial evaluation.\n\nExclusion Criteria:\n\nPatients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications."}, 'identificationModule': {'nctId': 'NCT03220958', 'briefTitle': 'Metoclopramide for Post Traumatic Headache', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'A Randomized Placebo Controlled Trial of IV Metoclopramide for Acute Post-traumatic Headache', 'orgStudyIdInfo': {'id': '2017-7898'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metoclopramide', 'description': 'Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip', 'interventionNames': ['Drug: Metoclopramide', 'Drug: Diphenhydramine', 'Drug: Normal saline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal saline, administered as an intravenous drip', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Metoclopramide', 'type': 'DRUG', 'description': 'Metoclopramide 20mg', 'armGroupLabels': ['Metoclopramide']}, {'name': 'Diphenhydramine', 'type': 'DRUG', 'description': 'Diphenhydramine 25mg', 'armGroupLabels': ['Metoclopramide']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': '100ml normal saline', 'armGroupLabels': ['Metoclopramide', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Benjamin W. Friedman, MD', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}