Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-01-08 @ 8:13 PM
Study NCT ID:
NCT00682734
Status:
COMPLETED
Last Update Posted:
2018-05-31
First Post:
2008-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metoclopramide for Migraine: A Dose Finding Study
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': 'D004155', 'term': 'Diphenhydramine'}], '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': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'befriedm@montefiore.org', 'phone': '718 920 6626', 'title': 'Benjamin Friedman', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Metoclopramide 10 mg Intravenous', 'description': 'Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous', 'otherNumAtRisk': 113, 'otherNumAffected': 8, 'seriousNumAtRisk': 113, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Metoclopramide 20 mg', 'description': 'Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous', 'otherNumAtRisk': 118, 'otherNumAffected': 8, 'seriousNumAtRisk': 118, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Metoclopramide 40 mg', 'description': 'Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous', 'otherNumAtRisk': 118, 'otherNumAffected': 7, 'seriousNumAtRisk': 118, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 7}], 'organSystem': 'Nervous system disorders'}], 'seriousEvents': [{'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '0.1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoclopramide 10 mg Intravenous', 'description': 'Metoclopramide 10mg intravenous + diphenhydramine 25mg intravenous'}, {'id': 'OG001', 'title': 'Metoclopramide 20 mg', 'description': 'Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous'}, {'id': 'OG002', 'title': 'Metoclopramide 40 mg', 'description': 'Metoclopramide 40mg intravenous + diphenhdyramine 25mg intravenous'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '2.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 60 minutes', 'description': 'Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metoclopramide 10 mg Intravenous', 'description': 'Metoclopramide 10 mg intravenous + diphenhydramine 25mg intravenous'}, {'id': 'FG001', 'title': 'Metoclopramide 20 mg Intravenous', 'description': 'Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous'}, {'id': 'FG002', 'title': 'Metoclopramide 40 mg Intravenous', 'description': 'Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous'}], 'periods': [{'title': 'Emergency Department Portion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '117'}, {'groupId': 'FG002', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': '48 Hour Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '117'}, {'groupId': 'FG002', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '349', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Metoclopramide 10 mg Intravenous', 'description': 'Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous'}, {'id': 'BG001', 'title': 'Metoclopramide 20 mg', 'description': 'Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous'}, {'id': 'BG002', 'title': 'Metoclopramide 40 mg', 'description': 'Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Adults', 'categories': [{'measurements': [{'value': '38.7', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '37.5', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '38.4', 'spread': '12.0', 'groupId': 'BG002'}, {'value': '38.2', 'spread': '11.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '294', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 349}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2008-05-19', 'resultsFirstSubmitDate': '2011-07-24', 'studyFirstSubmitQcDate': '2008-05-21', 'lastUpdatePostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-11-28', 'studyFirstPostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity Score', 'timeFrame': 'Baseline, 60 minutes', 'description': 'Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the best dose to administer. This study compares three different doses of metoclorpamide.', 'detailedDescription': 'Patients with acute migraine attacks are eligible for enrollment if they present to the emergency department of Montefiore Medical Center. Pain scores are assessed at baseline and every 30 minutes for two hours, and then again by telephone 48 hours after discharge'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute migraine\n\nExclusion Criteria:\n\n* secondary cause of headache\n* lumbar puncture\n* allergy or intolerance to study medication'}, 'identificationModule': {'nctId': 'NCT00682734', 'acronym': 'MDFS', 'briefTitle': 'Metoclopramide for Migraine: A Dose Finding Study', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Metoclopramide for Acute Migraine: A Dose Finding Study', 'orgStudyIdInfo': {'id': '07-11-405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes', 'interventionNames': ['Drug: metoclopramide', 'Drug: Diphenhydramine 25mg']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.', 'interventionNames': ['Drug: metoclopramide', 'Drug: Diphenhydramine 25mg']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.', 'interventionNames': ['Drug: metoclopramide', 'Drug: Diphenhydramine 25mg']}], 'interventions': [{'name': 'metoclopramide', 'type': 'DRUG', 'description': 'metoclopramide 20 mg', 'armGroupLabels': ['2']}, {'name': 'metoclopramide', 'type': 'DRUG', 'description': 'metoclopramide 40 mg', 'armGroupLabels': ['3']}, {'name': 'metoclopramide', 'type': 'DRUG', 'description': 'metoclopramide 10 mg', 'armGroupLabels': ['1']}, {'name': 'Diphenhydramine 25mg', 'type': 'DRUG', 'description': 'Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Benjamin W. Friedman, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Benjamin W. Friedman, MD', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}