Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-13 @ 5:49 PM
Study NCT ID:
NCT02764320
Status:
COMPLETED
Last Update Posted:
2021-11-12
First Post:
2016-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The MOTS (Medication Overuse Treatment Strategy) Trial
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Schwedt.Todd@mayo.edu', 'phone': '480-301-9443', 'title': 'Dr. Todd J. Schwedt', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Discontinuation', 'description': 'Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)\n\nDiscontinuation of Overused Medication: Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy', 'otherNumAtRisk': 361, 'deathsNumAtRisk': 361, 'otherNumAffected': 20, 'seriousNumAtRisk': 361, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Preventive Therapy Only', 'description': 'Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)\n\nMigraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)', 'otherNumAtRisk': 359, 'deathsNumAtRisk': 359, 'otherNumAffected': 16, 'seriousNumAtRisk': 359, 'deathsNumAffected': 1, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache Worsened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cecal Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache Worsened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint Range of Motion Decrease Cervical Spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left Ventricular Systolic Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical Procedure - Spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Moderate to Severe Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Discontinuation', 'description': 'Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)\n\nDiscontinuation of Overused Medication: Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy'}, {'id': 'OG001', 'title': 'Preventive Therapy Only', 'description': 'Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)\n\nMigraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected or analyzed on 16 subjects from the discontinuation arm. Data not collected or analyzed on 19 subjects from the preventive therapy only arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Discontinuation', 'description': 'Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)\n\nDiscontinuation of Overused Medication: Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy'}, {'id': 'FG001', 'title': 'Preventive Therapy Only', 'description': 'Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)\n\nMigraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '359'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '310'}, {'groupId': 'FG001', 'numSubjects': '310'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Health Issues unable to continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Overused medication unavailable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Seeking care outside site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Technology barriers', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '720', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Discontinuation', 'description': 'Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)\n\nDiscontinuation of Overused Medication: Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy'}, {'id': 'BG001', 'title': 'Preventive Therapy Only', 'description': 'Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)\n\nMigraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '13', 'groupId': 'BG000'}, {'value': '44', 'spread': '13', 'groupId': 'BG001'}, {'value': '44', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '313', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '630', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White Non-Hispanic', 'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '543', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '361', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '720', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-01', 'size': 1315654, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-28T14:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 720}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-10', 'studyFirstSubmitDate': '2016-05-04', 'resultsFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2016-05-04', 'lastUpdatePostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-10', 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Moderate to Severe Headache Days', 'timeFrame': '12 weeks', 'description': 'Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '38663902', 'type': 'DERIVED', 'citation': 'Whitaker DJ, Dumkrieger GM, Hentz JG, Dodick DW, Schwedt TJ. Physical impairment during and between migraine attacks: A daily diary study of patients with chronic migraine. Cephalalgia. 2024 Apr;44(4):3331024241249747. doi: 10.1177/03331024241249747.'}, {'pmid': '35169011', 'type': 'DERIVED', 'citation': 'Schwedt TJ, Hentz JG, Sahai-Srivastava S, Murinova N, Spare NM, Treppendahl C, Martin VT, Birlea M, Digre K, Watson D, Leonard M, Robert T, Dodick DW; MOTS Investigators. Patient-Centered Treatment of Chronic Migraine With Medication Overuse: A Prospective, Randomized, Pragmatic Clinical Trial. Neurology. 2022 Apr 5;98(14):e1409-e1421. doi: 10.1212/WNL.0000000000200117. Epub 2022 Feb 15.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'There are two commonly used treatment strategies for treating patients who have chronic migraine with medication overuse. This study will compare the outcomes amongst patients randomized to one of the two treatment strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Adults, at least 21 years of age\n* Chronic Migraine - diagnosed according to ICHD3beta criteria\n* Medication Overuse - diagnosed according to ICHD3beta criteria\n* Willingness to be randomized to either of the two treatment arms\n* Willingness to maintain a headache diary\n* Plan for follow-up care with the clinician\n* No changes to migraine prophylactic therapy within the 4 weeks prior to randomization.\n\nExclusion Criteria\n\n* Younger than 21 years of age\n* Headache diagnoses other than chronic migraine with medication overuse; episodic tension-type headache on 3 or fewer days per month is allowed\n* Not willing to be randomized to either of the treatment arms\n* Not willing to maintain a daily headache diary\n* Not planning on follow-up care with the clinician\n* In the opinion of the clinician, randomization to either treatment arm would be considered unsafe (ex: pregnancy, immediate discontinuation\n* Prisoners\n* Diminished decision-making capacity which in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures."}, 'identificationModule': {'nctId': 'NCT02764320', 'acronym': 'MOTS', 'briefTitle': 'The MOTS (Medication Overuse Treatment Strategy) Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse', 'orgStudyIdInfo': {'id': '16-001036'}, 'secondaryIdInfos': [{'id': 'PCORI', 'type': 'OTHER_GRANT', 'domain': 'PCS-1504-30133'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Discontinuation', 'description': 'Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)', 'interventionNames': ['Other: Discontinuation of Overused Medication']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Preventive Therapy Only', 'description': 'Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)', 'interventionNames': ['Other: Migraine Prophylactic Therapy Only']}], 'interventions': [{'name': 'Migraine Prophylactic Therapy Only', 'type': 'OTHER', 'description': 'Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)', 'armGroupLabels': ['Preventive Therapy Only']}, {'name': 'Discontinuation of Overused Medication', 'type': 'OTHER', 'description': 'Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy', 'armGroupLabels': ['Discontinuation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86001', 'city': 'Flagstaff', 'state': 'Arizona', 'country': 'United States', 'facility': 'Northern Arizona Healthcare Medical Group', 'geoPoint': {'lat': 35.19807, 'lon': -111.65127}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona Headache Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona Neurology Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Honor Health Neurology', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Thunderbird', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Medical Center of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver Headache Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80238', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver Primary Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'Blue Sky Neurology', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Healthcare', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Neurology', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham Women's Hospital Headache Clinic", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham Women's Hospital Neurology Clinic", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49201', 'city': 'Jackson', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Allegiance Health', 'geoPoint': {'lat': 42.24587, 'lon': -84.40135}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Headache 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'country': 'United States', 'facility': 'Toledo Clinic Adult Neurology', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital Headache Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15236', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Preferred Headache Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Primary Care', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah General Neurology', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 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