Efficacy, Tolerability, and Safety 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
631
1 country
43
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
43 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
January 4, 2017
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 (First Treated Double-blind Treatment Period)
The primary efficacy end point (for first treated DB1 attack only) were the percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]
2 hours postdose
Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose
Percentage of subjects who are free from their Most Bothersome Symptom (MBS) among nausea, photophobia, and phonophobia (first double-blind treatment period)
2 hours postdose
Secondary Outcomes (16)
The Number of Subjects With TEAEs After Study Drug Compared Between DFN-15 and Placebo
Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
15 minutes to 24 hours postdose
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
- +11 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 (43)
Site 609
Birmingham, Alabama, 35205, United States
Site 640
Mobile, Alabama, 36608, United States
Site 622
Tucson, Arizona, 85745, United States
Site 616
Hot Springs, Arkansas, 71901, United States
Site 637
Huntington Beach, California, 92647, United States
Site 615
Oakland, California, 94607, United States
Site 646
San Diego, California, 92108, United States
Site 619
San Francisco, California, 94102, United States
Site 624
San Marcos, California, 92078, United States
Site 631
Littleton, Colorado, 80127, United States
Site 603
Miami, Florida, 33176, United States
Site 641
Orange City, Florida, 32763, United States
Site 629
Orlando, Florida, 32801, United States
Site 601
West Palm Beach, Florida, 33409, United States
Site 625
Decatur, Georgia, 30034, United States
Site 630
Sandy Springs, Georgia, 30328, United States
Site 642
Meridian, Idaho, 83642, United States
Site 604
Blue Island, Illinois, 60406, United States
Site 602
Louisville, Kentucky, 40213, United States
Site 644
New Orleans, Louisiana, 70115, United States
Site 610
New Orleans, Louisiana, 70124, United States
Site 634
Ann Arbor, Michigan, 48104, United States
Site 623
Edina, Minnesota, 55435, United States
Site 638
City of Saint Peters, Missouri, 63303, United States
Site 606
Missoula, Montana, 59808, United States
Site 613
Omaha, Nebraska, 68134, United States
Site 647
Lebanon, New Hampshire, 03756, United States
Site 618
Nashua, New Hampshire, 03060, United States
Site 636
Albuquerque, New Mexico, 87102, United States
Site 645
Brooklyn, New York, 11229, United States
Site 608
Rochester, New York, 14609, United States
Site 620
High Point, North Carolina, 27262, United States
Site 643
Mooresville, North Carolina, 28117, United States
Site 626
Fargo, North Dakota, 58103, United States
Site 628
Cleveland, Ohio, 44122, United States
Site 614
Warwick, Rhode Island, 02886, United States
Site 639
Mt. Pleasant, South Carolina, 29464, United States
Site 612
Dakota Dunes, South Dakota, 57049, United States
Site 627
Austin, Texas, 78745, United States
Site 611
Dallas, Texas, 75231, United States
Site 632
San Antonio, Texas, 78240, United States
Site 621
Taylorsville, Utah, 84123, United States
Site 635
Richmond, Virginia, 23294, United States
Related Publications (1)
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.
PMID: 34447267DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Scientific Communications
- Organization
- BioDelivery Sciences (a subsidiary of Collegium Pharmaceutical)
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
January 4, 2017
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