Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-21 @ 12:13 AM
Study NCT ID:
NCT01211795
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2010-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Intra-Oral Ketoprofen for Migraine Prevention
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-04', 'studyFirstSubmitDate': '2010-09-27', 'studyFirstSubmitQcDate': '2010-09-28', 'lastUpdatePostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of migraine days per month', 'timeFrame': '3 months', 'description': 'Number of migraine days per month will be compared before gel use and at the end of 3 months of use.'}], 'secondaryOutcomes': [{'measure': 'Change in migraine severity', 'timeFrame': '3 month total', 'description': 'Average migraine severity on a scale of 1-10, will be compared prior to gel use, and at the end of 3 months'}, {'measure': 'Change in migraine duration', 'timeFrame': '3 months', 'description': 'Average migraine duration will be compared prior to gel use, and at the end of 3 months'}, {'measure': 'Change in headache medication use', 'timeFrame': '3 months', 'description': 'Change in headache medication use will be compared prior to gel use, and at the end of 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Migraine', 'Prevention', 'Treatment', 'Ketoprofen', 'Trigeminal nerve'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been shown to prevent migraines when used once daily for 3 months in open label studies. This is a randomized, double-blind, placebo controlled phase III prevention trial to determine safety and efficacy.', 'detailedDescription': 'This is a 4 month trial. During the first month, a prospective headache diary is maintained. Migraine frequency, severity (1-10), duration, and all headache medications are recorded.\n\nPatients are then randomized to receive active gel or placebo gel in double blind fashion.\n\nGel is applied to the posterior maxilla once daily for 3 months. A daily headache diary, as outlined above, is maintained throughout the trial. Patients may continue to take other migraine medications, as needed. No other new migraine therapies may be started during the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IHS Migraine with or without aura\n* 18 y.o. or older\n* at least 4 migraines per month\n\nExclusion Criteria:\n\n* pregnancy\n* other headache conditions\n* chronic daily headache\n* allergy or sensitivity to NSAIDs other severe illnesses'}, 'identificationModule': {'nctId': 'NCT01211795', 'briefTitle': 'Topical Intra-Oral Ketoprofen for Migraine Prevention', 'organization': {'class': 'INDIV', 'fullName': 'Behar, Caren, M.D.'}, 'officialTitle': 'Phase III Double Blind Randomized Placebo Controlled Trial Using 20% Intra-Oral Ketoprofen Gel for Migraine Prevention.', 'orgStudyIdInfo': {'id': 'IND 79,629'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Topical Ketoprofen gel', 'interventionNames': ['Drug: topical intraoral ketoprofen gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo gel', 'interventionNames': ['Other: Placebo Gel']}], 'interventions': [{'name': 'topical intraoral ketoprofen gel', 'type': 'DRUG', 'description': '20% ketoprofen oral gel is applied once daily by cotton swab to a branch of the trigeminal nerve on the maxillary gingival mucosa above the 2nd and 3rd molars. The swab is held in place for 2 minutes at the same time once daily.', 'armGroupLabels': ['Topical Ketoprofen gel']}, {'name': 'Placebo Gel', 'type': 'OTHER', 'description': "An identical oral gel, without ketoprofen, or 'placebo gel' is applied using a cotton swab, once daily to a branch of the trigeminal nerve on the maxillary gingival mucosa. It is held in place for 2 minutes, once daily.", 'armGroupLabels': ['Placebo gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}], 'overallOfficials': [{'name': 'Caren Behar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Behar, Caren, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'oldNameTitle': 'Caren Behar MD FACP', 'oldOrganization': 'NYMC'}}}}