Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
631 participants
INTERVENTIONAL
2016-12-31
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DFN-15 Active
DFN-15 Active
DFN-15 Active
DFN-15 Placebo
DFN-15 Placebo
DFN-15 Placebo
Interventions
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DFN-15 Active
DFN-15 Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who have migraine with or without aura with onset before age 50 years
3. Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale without treatment.
4. Subjects who are willing and able to:
1. Evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject eDiary for the duration of the study;
2. Record each instance of the use of study drug and rescue medication in real-time using a subject eDiary for the duration of the study;
3. Comply with all other study procedures and scheduling requirements.
Exclusion Criteria
2. Medication overuse:
1. Opioids greater than or equal to 10 days during the 90 days prior to screening
2. Combination medications (e.g., Fiorinal®) greater than or equal to 10 days during the 90 days prior to screening (applies only if includes opioid and/or barbiturate)
3. Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14 days a month during the 90 days prior to screening
4. Triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening
3. Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to screening. (If treated for cosmetic reasons, subjects may be included).
4. Current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization.
5. Patients who have received treatment with an investigational drug or device within 30 days of randomization, or participated in a central nervous system clinical trial within 2 months prior to randomization
6. Patients with positive screening test for human immunodeficiency virus \[HIV\], positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus \[HCV\] antibody
7. Subjects who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the clinical research study site.
18 Years
75 Years
ALL
No
Sponsors
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Dr. Reddy's Laboratories Limited
INDUSTRY
BioDelivery Sciences International
INDUSTRY
Responsible Party
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Locations
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Site 609
Birmingham, Alabama, United States
Site 640
Mobile, Alabama, United States
Site 622
Tucson, Arizona, United States
Site 616
Hot Springs, Arkansas, United States
Site 637
Huntington Beach, California, United States
Site 615
Oakland, California, United States
Site 646
San Diego, California, United States
Site 619
San Francisco, California, United States
Site 624
San Marcos, California, United States
Site 631
Littleton, Colorado, United States
Site 603
Miami, Florida, United States
Site 641
Orange City, Florida, United States
Site 629
Orlando, Florida, United States
Site 601
West Palm Beach, Florida, United States
Site 625
Decatur, Georgia, United States
Site 630
Sandy Springs, Georgia, United States
Site 642
Meridian, Idaho, United States
Site 604
Blue Island, Illinois, United States
Site 602
Louisville, Kentucky, United States
Site 644
New Orleans, Louisiana, United States
Site 610
New Orleans, Louisiana, United States
Site 634
Ann Arbor, Michigan, United States
Site 623
Edina, Minnesota, United States
Site 638
City of Saint Peters, Missouri, United States
Site 606
Missoula, Montana, United States
Site 613
Omaha, Nebraska, United States
Site 647
Lebanon, New Hampshire, United States
Site 618
Nashua, New Hampshire, United States
Site 636
Albuquerque, New Mexico, United States
Site 645
Brooklyn, New York, United States
Site 608
Rochester, New York, United States
Site 620
High Point, North Carolina, United States
Site 643
Mooresville, North Carolina, United States
Site 626
Fargo, North Dakota, United States
Site 628
Cleveland, Ohio, United States
Site 614
Warwick, Rhode Island, United States
Site 639
Mt. Pleasant, South Carolina, United States
Site 612
Dakota Dunes, South Dakota, United States
Site 627
Austin, Texas, United States
Site 611
Dallas, Texas, United States
Site 632
San Antonio, Texas, United States
Site 621
Taylorsville, Utah, United States
Site 635
Richmond, Virginia, United States
Countries
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References
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Lipton RB, Munjal S, Tepper SJ, Iaconangelo C, Serrano D. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Tolerability, and Safety of Celecoxib Oral Solution (ELYXYB) in Acute Treatment of Episodic Migraine with or without Aura. J Pain Res. 2021 Aug 19;14:2529-2542. doi: 10.2147/JPR.S322292. eCollection 2021.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Publication of study results
Other Identifiers
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DFN-15-CD-006
Identifier Type: -
Identifier Source: org_study_id
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