Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-29 @ 6:00 PM
Study NCT ID:
NCT01916395
Status:
COMPLETED
Last Update Posted:
2013-08-05
First Post:
2013-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Treximet & Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018170', 'term': 'Sumatriptan'}, {'id': 'C000611385', 'term': 'sumatriptan-naproxen'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-02', 'studyFirstSubmitDate': '2013-08-02', 'studyFirstSubmitQcDate': '2013-08-02', 'lastUpdatePostDateStruct': {'date': '2013-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The outcome will be to determine whether inflammatory markers are reduced in patients having a migraine when treated with Imitrex 100mg or Treximet.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Migraine'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine whether inflammatory markers, such as C-Reactive Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP), or Substance P (SP) are reduced in patients having a migraine headache when treated with Imitrex or Treximet.\n\nThe secondary objective is to determine the effects of Imitrex and Treximet on C-Reactive Protein (CRP) in patients with active migraine headaches.', 'detailedDescription': 'Migraine is a neurovascular process involving the brain and related structures. Neuroinflammatory substances such as CRP, CGRP, VIP, SP, and prostaglandins are liberated during the migraine. Elevation of these markers may be associated with other conditions which contain an inflammatory component such as coronary artery disease. VIP is an inflammation and pain transmission, and thus are markers of sensory nociceptive neurons.\n\nDuring this study, the subjects will have the following inflammation markers analyzed: C-Reactive Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP), and Substance P (SP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female patients with migraine headaches.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must sign an informed consent\n* Males and females 18 - 65 years of age\n* Have episodic migraine headaches\n* Patients to satisfy the diagnosis of migraine headaches with aura, without aura or mixed\n* Must be able to differentiate migraine headaches from other headaches\n* Diagnosis of migraines for at least 6 months\n\nExclusion Criteria:\n\n* Any medical condition, in the opinion of the investigator, that would make the subject unsuitable for enrollment\n* Basilar or hemiplegic migraine headaches\n* Pregnant woman or a nursing mother\n* History (within 1 year) or current evidence of grug or alcohol abuse\n* More than 15 migraine headaches per month\n* Chronic daily headache\n* Chronic use of NonSteroidalAntiInglammatoryDrugs\n* Current participation in a research study or within the last 30 days'}, 'identificationModule': {'nctId': 'NCT01916395', 'briefTitle': 'Comparison of Treximet & Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache', 'organization': {'class': 'OTHER', 'fullName': 'Westside Family Medical Center, P.C.'}, 'officialTitle': 'Comparison of Treximet and Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache.', 'orgStudyIdInfo': {'id': 'GR10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Imitrex and Treximet', 'description': 'Imitrex 100mg as needed Treximet 85/500mg', 'interventionNames': ['Drug: sumatriptan and Treximet']}], 'interventions': [{'name': 'sumatriptan and Treximet', 'type': 'DRUG', 'otherNames': ['Imitrex 100mg', 'Treximet 85/500mg'], 'description': 'sumatriptan 100mg tablet when migraine is moderate or severe in intensity. Treximet 85/500mg tablet when migraine is moderate or severe in intensity.', 'armGroupLabels': ['Imitrex and Treximet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49009', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Westside Family Medical Center, PC', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}], 'overallOfficials': [{'name': 'Gary E Ruoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Family Practice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gary E. Ruoff, M.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Research', 'investigatorFullName': 'Gary E. Ruoff, M.D.', 'investigatorAffiliation': 'Westside Family Medical Center, P.C.'}}}}