Clinical trial NCT03009019: Efficacy, Tolerability, and Safety of DFN-15
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Tolerability, and Safety Study of DFN-15 in Episodic Migraine With or Without Aura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Headache
Lead sponsor: BioDelivery Sciences International
Sponsor class: INDUSTRY
Collaborators: name: Dr. Reddy's Laboratories Limited
First posted: 2017-01-04
Enrollment: 631
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. 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.
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:

1. Minors, even if they are in the specified study age range
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.

Primary outcomes:
measure: Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (First Treated Double-blind Treatment Period)
timeFrame: 2 hours postdose
measure: Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose
timeFrame: 2 hours postdose
Secondary outcomes:
measure: The Number of Subjects With TEAEs After Study Drug Compared Between DFN-15 and Placebo
timeFrame: Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
measure: Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
timeFrame: 15 minutes to 24 hours postdose
measure: Time to Headache Pain Relief Postdose (DB1 and DB2)
timeFrame: 2 hours postdose
measure: Time to Headache Pain Freedom Postdose (DB1 and DB2)
timeFrame: 2 hours postdose
measure: Headache Pain Relief Postdose (DB1 and DB2)
timeFrame: 15 minutes to 24 hours postdose
measure: Headache Pain Freedom Postdose (DB1 and DB2)
timeFrame: 15 minutes to 24 hours postdose
measure: Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
timeFrame: 15 minutes to 24 hours postdose
measure: Change in Functional Disability Score Postdose (DB1 and DB2)
timeFrame: 2 to 24 hours postdose
measure: Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2)
timeFrame: 2 and 4 hours postdose
measure: Headache Pain Freedom Among BMI Category (DB1 and DB2)
timeFrame: 2 and 4 hours postdose
measure: Headache Pain Recurrence Postdose (DB1 and DB2)
timeFrame: 2 to 24 hours postdose
measure: Sustained Headache Pain Relief Postdose (DB1 and DB2)
timeFrame: 2 to 24 hours postdose
measure: Sustained Headache Pain Freedom Postdose (DB1 and DB2)
timeFrame: 2 to 24 hours postdose
measure: Use of Rescue Medication Postdose (DB1 and DB2)
timeFrame: 2 to 24 hours postdose
measure: Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2)
timeFrame: 2 and 4 hours postdose
measure: Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
timeFrame: 24 hours postdose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 609
state: Alabama
city: Mobile
country: United States
facility: Site 640
state: Alabama
city: Tucson
country: United States
facility: Site 622
state: Arizona
city: Hot Springs
country: United States
facility: Site 616
state: Arkansas
city: Huntington Beach
country: United States
facility: Site 637
state: California
city: Oakland
country: United States
facility: Site 615
state: California
city: San Diego
country: United States
facility: Site 646
state: California
city: San Francisco
country: United States
facility: Site 619
state: California
city: San Marcos
country: United States
facility: Site 624
state: California
city: Littleton
country: United States
facility: Site 631
state: Colorado
city: Miami
country: United States
facility: Site 603
state: Florida
city: Orange City
country: United States
facility: Site 641
state: Florida
city: Orlando
country: United States
facility: Site 629
state: Florida
city: West Palm Beach
country: United States
facility: Site 601
state: Florida
city: Decatur
country: United States
facility: Site 625
state: Georgia
city: Sandy Springs
country: United States
facility: Site 630
state: Georgia
city: Meridian
country: United States
facility: Site 642
state: Idaho
city: Blue Island
country: United States
facility: Site 604
state: Illinois
city: Louisville
country: United States
facility: Site 602
state: Kentucky
city: New Orleans
country: United States
facility: Site 644
state: Louisiana
city: New Orleans
country: United States
facility: Site 610
state: Louisiana
city: Ann Arbor
country: United States
facility: Site 634
state: Michigan
city: Edina
country: United States
facility: Site 623
state: Minnesota
city: Saint Peters
country: United States
facility: Site 638
state: Missouri
city: Missoula
country: United States
facility: Site 606
state: Montana
city: Omaha
country: United States
facility: Site 613
state: Nebraska
city: Lebanon
country: United States
facility: Site 647
state: New Hampshire
city: Nashua
country: United States
facility: Site 618
state: New Hampshire
city: Albuquerque
country: United States
facility: Site 636
state: New Mexico
city: Brooklyn
country: United States
facility: Site 645
state: New York
city: Rochester
country: United States
facility: Site 608
state: New York
city: High Point
country: United States
facility: Site 620
state: North Carolina
city: Mooresville
country: United States
facility: Site 643
state: North Carolina
city: Fargo
country: United States
facility: Site 626
state: North Dakota
city: Cleveland
country: United States
facility: Site 628
state: Ohio
city: Warwick
country: United States
facility: Site 614
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Site 639
state: South Carolina
city: Dakota Dunes
country: United States
facility: Site 612
state: South Dakota
city: Austin
country: United States
facility: Site 627
state: Texas
city: Dallas
country: United States
facility: Site 611
state: Texas
city: San Antonio
country: United States
facility: Site 632
state: Texas
city: Taylorsville
country: United States
facility: Site 621
state: Utah
city: Richmond
country: United States
facility: Site 635
state: Virginia
Study officials:
References:
citation: 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.