Ignite Creation Date:
2025-12-24 @ 12:45 PM
Ignite Modification Date:
2025-12-24 @ 12:45 PM
Study NCT ID:
NCT00471861
Status:
COMPLETED
Last Update Posted:
2011-08-08
First Post:
2007-05-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inflammatory Markers in Patients With Active Migraine Headaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-05', 'studyFirstSubmitDate': '2007-05-08', 'studyFirstSubmitQcDate': '2007-05-08', 'lastUpdatePostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-10', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inflammatory Markers', 'Migraine'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether C-Reactive Protein (CRP) is elevated in patients with active migraine headaches. Secondary goal is to determine whether other inflammatory markers, such as Calcitonin Gene Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP) or Substance P (SP) are elevated in patients having a migraine headache.', 'detailedDescription': 'A random selection of patients both male and female from a primary care practice with a diagnosis of having migraine headaches will be enrolled. Thirty (30) patients will be recruited mainly from the primary care practice. Recruitment will include males and females aged 21-65. The patients who meet the inclusion criteria will be enrolled. The patients who do not have migraine headaches will also be enrolled and function as controls. Non-migraine patients will meet inclusion criteria 1, 2 and 3 and all of the exclusion criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Migraine', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must sign a written informed consent.\n2. Enrollment population would include males and females 21 years of age to 65 years of age.\n3. Non-migraine subjects will be allowed in the control group\n4. Have episodic migraine headaches\n5. Patients to satisfy the diagnosis of migraine headaches with aura, without aura or mixed.\n6. Must be able to differentiate migraine headaches from other headaches\n\nExclusion Criteria:\n\n1. Any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment.\n2. Basilar or hemiplegic migraine headaches.\n3. Pregnant woman or a nursing mother\n4. History (within 1 year) or current evidence of drug or alcohol abuse.\n5. More than 15 migraine headaches per month\n6. Chronic daily headaches\n7. Chronic use of NSAIDs\n8. Current participation in a research study or within the last 30 days.'}, 'identificationModule': {'nctId': 'NCT00471861', 'briefTitle': 'Inflammatory Markers in Patients With Active Migraine Headaches', 'organization': {'class': 'OTHER', 'fullName': 'Westside Family Medical Center, P.C.'}, 'officialTitle': 'Does Migraine As A Partly Inflammatory Disease Increase The Inflammatory Markers Of The Patient When Actively Having a Migraine?', 'orgStudyIdInfo': {'id': '109944'}}, 'contactsLocationsModule': {'locations': [{'zip': '49009', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Westside Family Medical Center, P.C.', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}], 'overallOfficials': [{'name': 'Gary E Ruoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Westside Family Medical Center, P.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Westside Family Medical Center, P.C.', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Gary E. Ruoff', 'oldOrganization': 'Westside Family Medical Center'}}}}