Efficacy, Tolerability, and Safety Study of DFN-15
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Tolerability, and Safety Study of DFN-15 in Episodic Migraine With or Without Aura
1 other identifier
interventional
622
1 country
45
Brief Summary
Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2016
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 27, 2016
CompletedFirst Posted
Study publicly available on registry
December 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedResults Posted
Study results publicly available
January 10, 2023
CompletedJanuary 10, 2023
December 1, 2022
11 months
December 27, 2016
April 22, 2022
December 15, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (DB1)
Percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo in the DB1 period (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]) during DB1.
2 hours post dose
Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose (DB1)
Percentage of subjects who are free from their most bothersome symptom (MBS) among nausea, photophobia, and phonophobia at 2 hours postdose during DB1.
2 hours post dose
Secondary Outcomes (15)
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
15 minutes through 24 hours
Time to Headache Pain Relief Postdose (DB1 and DB2)
2 hours postdose
Time to Headache Pain Freedom Postdose (DB1 and DB2)
2 hours postdose
Headache Pain Relief Postdose (DB1 and DB2)
15 minutes to 24 hours postdose
Headache Pain Freedom Postdose (DB1 and DB2)
15 minutes to 24 hours postdose
- +10 more secondary outcomes
Study Arms (2)
DFN-15 Active
EXPERIMENTALDFN-15 Active
DFN-15 Placebo
PLACEBO COMPARATORDFN-15 Placebo
Interventions
Eligibility Criteria
You may qualify if:
- A history of episodic migraine, who experience 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks.
- Patients who have migraine with or without aura with onset before age 50 years
- Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale without treatment.
- Subjects who are willing and able to:
- Evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject eDiary for the duration of the study;
- 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;
- Comply with all other study procedures and scheduling requirements.
You may not qualify if:
- Minors, even if they are in the specified study age range
- Medication overuse:
- Opioids greater than or equal to 10 days during the 90 days prior to screening
- 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)
- Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14 days a month during the 90 days prior to screening
- Triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening
- Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to screening. (If treated for cosmetic reasons, subjects may be included).
- Current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization.
- 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
- Patients with positive screening test for human immunodeficiency virus \[HIV\], positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus \[HCV\] antibody
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Site 744
Birmingham, Alabama, 35216, United States
Site 727
Phoenix, Arizona, 85018, United States
Site 723
Little Rock, Arkansas, 72211, United States
Site 718
Rogers, Arkansas, 72758, United States
Site 709
Los Angeles, California, 90017, United States
Site 708
Orange, California, 92868, United States
Site 729
San Diego, California, 92103, United States
Site 725
Santa Monica, California, 90404, United States
Site 738
Simi Valley, California, 93065, United States
Site 733
Upland, California, 91786, United States
Site 726
Colorado Springs, Colorado, 80907, United States
Site 735
DeLand, Florida, 32720, United States
Site 711
Hialeah, Florida, 33016, United States
Site 721
Jacksonville, Florida, 32256, United States
Site 740
Blue Ridge, Georgia, 30513, United States
Site 720
Decatur, Georgia, 30030, United States
Site 734
West Des Moines, Iowa, 50265, United States
Site 739
Prairie Village, Kansas, 66208, United States
Site 713
Wichita, Kansas, 67205, United States
Site 706
Shreveport, Louisiana, 71105, United States
Site 712
Baltimore, Maryland, 21236, United States
Site 703
Boston, Massachusetts, 02131, United States
Site 730
New Bedford, Massachusetts, 02740, United States
Site 704
Minneapolis, Minnesota, 55402, United States
Site 736
Hazelwood, Missouri, 63042, United States
Site 737
Springfield, Missouri, 65807, United States
Site 745
Las Vegas, Nevada, 89103, United States
Site 716
Berlin, New Jersey, 08009, United States
Site 746
Amherst, New York, 14226, United States
Site 705
Manhattan, New York, 10018, United States
Site 743
Williamsville, New York, 14221, United States
Site 715
Raleigh, North Carolina, 27612, United States
Site 728
Cincinnati, Ohio, 45255, United States
Site 707
Dayton, Ohio, 45424, United States
Site 701
Oklahoma City, Oklahoma, 73103, United States
Site 741
Salem, Oregon, 97301, United States
Site 717
Media, Pennsylvania, 19063, United States
Site 731
Philadelphia, Pennsylvania, 19107, United States
Site 742
Lincoln, Rhode Island, 02865, United States
Site 710
Anderson, South Carolina, 29621, United States
Site 724
Chattanooga, Tennessee, 37421, United States
Site 719
Austin, Texas, 78731, United States
Site 702
Plano, Texas, 75024, United States
Site 714
Virginia Beach, Virginia, 23454, United States
Site 722
Bellevue, Washington, 98007, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Todd Kunkel, PharmD Director, Scientific Communications
- Organization
- BioDelivery Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2016
First Posted
December 30, 2016
Study Start
December 1, 2016
Primary Completion
November 1, 2017
Study Completion
May 1, 2019
Last Updated
January 10, 2023
Results First Posted
January 10, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share