Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
622 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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BioDelivery Sciences International
INDUSTRY
Responsible Party
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Locations
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Site 744
Birmingham, Alabama, United States
Site 727
Phoenix, Arizona, United States
Site 723
Little Rock, Arkansas, United States
Site 718
Rogers, Arkansas, United States
Site 709
Los Angeles, California, United States
Site 708
Orange, California, United States
Site 729
San Diego, California, United States
Site 725
Santa Monica, California, United States
Site 738
Simi Valley, California, United States
Site 733
Upland, California, United States
Site 726
Colorado Springs, Colorado, United States
Site 735
DeLand, Florida, United States
Site 711
Hialeah, Florida, United States
Site 721
Jacksonville, Florida, United States
Site 740
Blue Ridge, Georgia, United States
Site 720
Decatur, Georgia, United States
Site 734
West Des Moines, Iowa, United States
Site 739
Prairie Village, Kansas, United States
Site 713
Wichita, Kansas, United States
Site 706
Shreveport, Louisiana, United States
Site 712
Baltimore, Maryland, United States
Site 703
Boston, Massachusetts, United States
Site 730
New Bedford, Massachusetts, United States
Site 704
Minneapolis, Minnesota, United States
Site 736
Hazelwood, Missouri, United States
Site 737
Springfield, Missouri, United States
Site 745
Las Vegas, Nevada, United States
Site 716
Berlin, New Jersey, United States
Site 746
Amherst, New York, United States
Site 705
Manhattan, New York, United States
Site 743
Williamsville, New York, United States
Site 715
Raleigh, North Carolina, United States
Site 728
Cincinnati, Ohio, United States
Site 707
Dayton, Ohio, United States
Site 701
Oklahoma City, Oklahoma, United States
Site 741
Salem, Oregon, United States
Site 717
Media, Pennsylvania, United States
Site 731
Philadelphia, Pennsylvania, United States
Site 742
Lincoln, Rhode Island, United States
Site 710
Anderson, South Carolina, United States
Site 724
Chattanooga, Tennessee, United States
Site 719
Austin, Texas, United States
Site 702
Plano, Texas, United States
Site 714
Virginia Beach, Virginia, United States
Site 722
Bellevue, Washington, United States
Countries
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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-007
Identifier Type: -
Identifier Source: org_study_id
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