Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT02472418
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Dose Levels of DFN-15 vs. Placebo in Patients With 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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'dispFirstSubmitDate': '2018-05-15', 'completionDateStruct': {'date': '2016-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-17', 'studyFirstSubmitDate': '2015-06-08', 'dispFirstSubmitQcDate': '2018-05-17', 'studyFirstSubmitQcDate': '2015-06-11', 'dispFirstPostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Free, defined as a score of "0" on a numerical scale of "0" to "3"', 'timeFrame': '2 hour', 'description': 'Percentage of subjects who are migraine headache free at 2 hours after taking study drug administration'}]}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '29158678', 'type': 'RESULT', 'citation': 'Munjal S, Bennett A. Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study. Neuropsychiatr Dis Treat. 2017 Nov 7;13:2797-2802. doi: 10.2147/NDT.S151834. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'Crossover study of DFN-15 dose A versus DFN-15 dose B versus Placebo in the treatment of migraine headaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a history of episodic migraine (as defined by International Classification of Headache Disorders \\[ICHD\\]-228) who experience an average of 2 to 6 migraine attacks a month for the past 12 months with no more than 14 headache days per month, and with at least 48 hours of headache-free time between migraine attacks;\n2. Patients with onset of migraine with or without aura before age 50;\n3. Patients who have migraine with or without aura, in which the aura cannot last longer than 60 minutes;\n4. Patients who report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale.\n\nExclusion Criteria:\n\n1. Patients with medication overuse headache (MOH) as defined by ICHD-228:\n\n * Opioids ≥ 10 days a month during the 90 days prior to screening\n * Combination medications (eg, Fiorinal® ≥ 10 days a month)\n * Nonsteroidal anti-inflammatory drugs (NSAIDs) or other simple medications \\> 14 days a month during the 90 days prior to screening\n * Triptans or ergots ≥ 10 days a month during the 90 days prior to screening\n2. Patients on chronic warfarin sodium;\n3. Patients taking monoamine oxidase-A (MAO-A) inhibitors;\n4. Patients on unstable dosages of chronic medications during the 3 months prior to and through screening, or who are not willing or able to maintain a stable pre-study dose throughout study participation;\n5. Patients with more than 6 migraine attacks a month and/or more than 14 headache days a month (based upon patient self-report);\n6. Patients with hemiplegic migraine or migraine with brain stem aura or other forms of neurologically complicated migraine;\n7. Patients with atypical aura;\n8. Patients with prolonged aura (more than 1 hour).\n9. Patients with a history of stroke or transient ischemic attack;\n10. Patients with a history of migralepsy or a concurrent diagnosis of seizure disorder;\n11. Patients who cannot differentiate between a migraine headache and a tension-type or cluster headache or any other non-migraine headache;\n12. Patients with a history of more than 10 tension-type headaches per month;\n13. Patients with a history of cluster headache;\n14. Patients with a diagnosis of ICHD-2 "probable migraine";\n15. Patients with uncontrolled hypertension (screening blood pressure ≥ 140/90 mmHg despite appropriate pharmacotherapy);\n16. Patients with severe renal impairment (defined as serum creatinine \\> 1.9 mg/dL);\n17. Patients with serum total bilirubin \\> 1.9 mg/dL;\n18. Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase \\> 3 times the upper limit of normal;\n19. Patients with positive serology for human immunodeficiency virus (HIV), Hepatitis B surface antigen, Hepatitis C antibody.\n20. Patients with a history of alcohol or substance abuse (including marijuana and medical marijuana) within 1 year that would compromise data collection;\n21. Patients with a history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the investigator, would compromise data collection;\n22. Patients with any other medical condition that, in the judgment of the investigator or medical monitor, would confound the objectives of the study (eg, cancer history \\[except basal cell carcinoma\\], systemic lupus erythematosus);\n23. Patients who have participated in a clinical trial involving any medication during the past 30 days or 5 half-lives of the study medication, whichever is longer'}, 'identificationModule': {'nctId': 'NCT02472418', 'briefTitle': 'Two Dose Levels of DFN-15 vs. Placebo in Patients With Migraine Headaches', 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': 'A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study Evaluating Efficacy of DFN-15 in Patients With Migraine Headache With or Without Aura', 'orgStudyIdInfo': {'id': 'DFN-15-CD-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DFN-15 120 mg (treatment A)', 'description': 'DFN-15 120 mg (treatment A)', 'interventionNames': ['Drug: DFN-15 Dose A (treatment A)']}, {'type': 'EXPERIMENTAL', 'label': 'DFN-15 240 mg (treatment B)', 'description': 'DFN-15 240 mg (treatment B)', 'interventionNames': ['Drug: DFN-15 Dose B (treatment B)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (treatment C)', 'description': 'Placebo (treatment C)', 'interventionNames': ['Other: Placebo (treatment C)']}], 'interventions': [{'name': 'DFN-15 Dose A (treatment A)', 'type': 'DRUG', 'otherNames': ['DFN-15 120 mg'], 'description': 'DFN-15 Dose A administered', 'armGroupLabels': ['DFN-15 120 mg (treatment A)']}, {'name': 'DFN-15 Dose B (treatment B)', 'type': 'DRUG', 'otherNames': ['DFN-15 240 mg'], 'description': 'DFN-15 Dose B administered', 'armGroupLabels': ['DFN-15 240 mg (treatment B)']}, {'name': 'Placebo (treatment C)', 'type': 'OTHER', 'otherNames': ['Placebo (no active ingredient)'], 'description': 'Placebo administered', 'armGroupLabels': ['Placebo (treatment C)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, LLC', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'California Medical Clinic for Headache', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MedVadis Research Corporation', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Head Pain & Neurological Institute', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinvest/ A Division of Banyan Group, Inc.', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Albuquerque Clinical Trials, Inc.', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}