Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 2:07 PM
Study NCT ID:
NCT05536050
Status:
UNKNOWN
Last Update Posted:
2022-10-27
First Post:
2022-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-25', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness on migraine', 'timeFrame': '9-12 weeks', 'description': 'Monthly migraine days'}], 'secondaryOutcomes': [{'measure': 'Effectiveness on headache', 'timeFrame': '9-12 weeks', 'description': 'Monthly headache days'}, {'measure': 'Intensity', 'timeFrame': '9-12 weeks', 'description': 'Average peak intensity of migraine'}, {'measure': 'The Migraine Disability Assessment Test', 'timeFrame': '9-12 weeks', 'description': 'Impact of migraine on daily life'}, {'measure': 'Migraine Specific Quality of Life Index', 'timeFrame': '9-12 weeks', 'description': 'Impact of migraine and migraine treatment on quality of life'}, {'measure': 'Patient Health Questionnaire', 'timeFrame': '9-12 weeks', 'description': 'Monitor depression and changes in signs/symptoms of depression'}, {'measure': 'Fibromyalgia Impact Questionnaire', 'timeFrame': '9-12 weeks', 'description': 'Assess health status of patients with fibromyalgia'}, {'measure': "Patients' Global Impression of Change", 'timeFrame': '9-12 weeks', 'description': "Assess patient's belief in efficacy of treatment"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Migraine', 'Fibromyalgia', 'New Daily Persistent Headache']}, 'descriptionModule': {'briefSummary': 'This research aims to look at the effect of low-dose naltrexone on the severity and frequency of attacks in people with chronic migraine with or without new daily persistent headache and fibromyalgia. A few studies suggest low-dose naltrexone is effective for fibromyalgia, but it has not been studied in patients with migraine and headaches. Our goal is to see if there is an improvement in either severity and frequency of attacks and overall impact on quality of life over a three-month period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be screened and enrolled by study personnel either during their visit with their referring physician, or remotely.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects will be adults of all genders ages 18 and older.\n* Patients with a diagnosis of CM (with or without NDPH) by IHC-3 criteria, diagnosed by a certified headache specialist.\n* Subjects who received a new prescription for LDN\n* Fibromyalgia-diagnosed according to Fibromyalgia Rapid Screening Tool\n* Subjects should be on stable headache and migraine preventives for the past 2 months with no plans to change medication for the next 4 months.\n* Subjects willing to maintain a headache/migraine diary one month prior to taking medication and while taking the medication, either physical or electronic diary of their choice.\n* Subjects willing to fill out pre and post intervention surveys\n* Subjects willing to comply with planned follow up phone calls and visits.\n\nExclusion Criteria:\n\n* Not planning on follow up care with clinician.\n* Patients with decreased decision-making capacity in which the investigator's opinion would interfere with the person's ability to provide informed consent and complete study questionnaires."}, 'identificationModule': {'nctId': 'NCT05536050', 'briefTitle': 'Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Prospective Observational Pilot Study of Low-dose Naltrexone in Patients With Chronic Migraine With Comorbid Fibromyalgia', 'orgStudyIdInfo': {'id': '22D.486'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Migraine diary and Questionnaires', 'type': 'OTHER', 'description': 'Patients who already have a prescription for low-dose naltrexone will be administered questionnaires twice during the trial. Additionally, patients will maintain migraine diary for the duration of the trial.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Marmura, MD', 'role': 'CONTACT', 'email': 'michael.marmura@jefferson.edu', 'phone': '215-955-2243'}, {'name': 'Joshua B Katz, BA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nathalia Figueiredo, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jefferson Headache Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}