Clinical trial NCT03006276: Efficacy, Tolerability, and Safety Study 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
First posted: 2016-12-30
Enrollment: 622
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 (DB1)
timeFrame: 2 hours post dose
measure: Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose (DB1)
timeFrame: 2 hours post dose
Secondary outcomes:
measure: Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
timeFrame: 15 minutes through 24 hours
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 to 4 hours postdose
measure: Headache Pain Freedom Among BMI Category (DB1 and DB2)
timeFrame: 2 to 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 to 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 744
state: Alabama
city: Phoenix
country: United States
facility: Site 727
state: Arizona
city: Little Rock
country: United States
facility: Site 723
state: Arkansas
city: Rogers
country: United States
facility: Site 718
state: Arkansas
city: Los Angeles
country: United States
facility: Site 709
state: California
city: Orange
country: United States
facility: Site 708
state: California
city: San Diego
country: United States
facility: Site 729
state: California
city: Santa Monica
country: United States
facility: Site 725
state: California
city: Simi Valley
country: United States
facility: Site 738
state: California
city: Upland
country: United States
facility: Site 733
state: California
city: Colorado Springs
country: United States
facility: Site 726
state: Colorado
city: DeLand
country: United States
facility: Site 735
state: Florida
city: Hialeah
country: United States
facility: Site 711
state: Florida
city: Jacksonville
country: United States
facility: Site 721
state: Florida
city: Blue Ridge
country: United States
facility: Site 740
state: Georgia
city: Decatur
country: United States
facility: Site 720
state: Georgia
city: West Des Moines
country: United States
facility: Site 734
state: Iowa
city: Prairie Village
country: United States
facility: Site 739
state: Kansas
city: Wichita
country: United States
facility: Site 713
state: Kansas
city: Shreveport
country: United States
facility: Site 706
state: Louisiana
city: Baltimore
country: United States
facility: Site 712
state: Maryland
city: Boston
country: United States
facility: Site 703
state: Massachusetts
city: New Bedford
country: United States
facility: Site 730
state: Massachusetts
city: Minneapolis
country: United States
facility: Site 704
state: Minnesota
city: Hazelwood
country: United States
facility: Site 736
state: Missouri
city: Springfield
country: United States
facility: Site 737
state: Missouri
city: Las Vegas
country: United States
facility: Site 745
state: Nevada
city: Berlin
country: United States
facility: Site 716
state: New Jersey
city: Amherst
country: United States
facility: Site 746
state: New York
city: Manhattan
country: United States
facility: Site 705
state: New York
city: Williamsville
country: United States
facility: Site 743
state: New York
city: Raleigh
country: United States
facility: Site 715
state: North Carolina
city: Cincinnati
country: United States
facility: Site 728
state: Ohio
city: Dayton
country: United States
facility: Site 707
state: Ohio
city: Oklahoma City
country: United States
facility: Site 701
state: Oklahoma
city: Salem
country: United States
facility: Site 741
state: Oregon
city: Media
country: United States
facility: Site 717
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site 731
state: Pennsylvania
city: Lincoln
country: United States
facility: Site 742
state: Rhode Island
city: Anderson
country: United States
facility: Site 710
state: South Carolina
city: Chattanooga
country: United States
facility: Site 724
state: Tennessee
city: Austin
country: United States
facility: Site 719
state: Texas
city: Plano
country: United States
facility: Site 702
state: Texas
city: Virginia Beach
country: United States
facility: Site 714
state: Virginia
city: Bellevue
country: United States
facility: Site 722
state: Washington
Study officials:
References: