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Efficacy, Tolerability, and Safety Study of DFN-15

Sponsor
BioDelivery Sciences International (Industry)
Overall Status
Completed
CT.gov ID
NCT03006276
Collaborator
(none)
622
Enrollment
45
Locations
2
Arms
28.9
Duration (Months)
13.8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: DFN-15 Active
  • Other: DFN-15 Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
622 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: DFN-15 Active

DFN-15 Active

Drug: DFN-15 Active
Other Names:
  • Celecoxib Oral Solution

    		•
    Placebo Comparator: DFN-15 Placebo

    DFN-15 Placebo

    Other: DFN-15 Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of subjects who are pain-free at 2 hours postdose (first double-blind treatment period) [2 hours post dose]

    2. Proportion of subjects who are free from their most bothersome symptom among nausea, photophobia, and phonophobia at 2 hours postdose (first double-blind treatment period. [2 hours post dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    5. Evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject eDiary for the duration of the study;

    6. 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;

    7. 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:

    3. Opioids greater than or equal to 10 days during the 90 days prior to screening

    4. 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)

    5. Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14 days a month during the 90 days prior to screening

    6. Triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening

    7. Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to screening. (If treated for cosmetic reasons, subjects may be included).

    8. Current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization.

    9. 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

    10. Patients with positive screening test for human immunodeficiency virus [HIV], positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus [HCV] antibody

    11. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 744 Birmingham Alabama United States 35216
    2 Site 727 Phoenix Arizona United States 85018
    3 Site 723 Little Rock Arkansas United States 72211
    4 Site 718 Rogers Arkansas United States 72758
    5 Site 709 Los Angeles California United States 90017
    6 Site 708 Orange California United States 92868
    7 Site 729 San Diego California United States 92103
    8 Site 725 Santa Monica California United States 90404
    9 Site 738 Simi Valley California United States 93065
    10 Site 733 Upland California United States 91786
    11 Site 726 Colorado Springs Colorado United States 80907
    12 Site 735 DeLand Florida United States 32720
    13 Site 711 Hialeah Florida United States 33016
    14 Site 721 Jacksonville Florida United States 32256
    15 Site 740 Blue Ridge Georgia United States 30513
    16 Site 720 Decatur Georgia United States 30030
    17 Site 734 West Des Moines Iowa United States 50265
    18 Site 739 Prairie Village Kansas United States 66208
    19 Site 713 Wichita Kansas United States 67205
    20 Site 706 Shreveport Louisiana United States 71105
    21 Site 712 Baltimore Maryland United States 21236
    22 Site 703 Boston Massachusetts United States 02131
    23 Site 730 New Bedford Massachusetts United States 02740
    24 Site 704 Minneapolis Minnesota United States 55402
    25 Site 736 Hazelwood Missouri United States 63042
    26 Site 737 Springfield Missouri United States 65807
    27 Site 745 Las Vegas Nevada United States 89103
    28 Site 716 Berlin New Jersey United States 08009
    29 Site 746 Amherst New York United States 14226
    30 Site 705 Manhattan New York United States 10018
    31 Site 743 Williamsville New York United States 14221
    32 Site 715 Raleigh North Carolina United States 27612
    33 Site 728 Cincinnati Ohio United States 45255
    34 Site 707 Dayton Ohio United States 45424
    35 Site 701 Oklahoma City Oklahoma United States 73103
    36 Site 741 Salem Oregon United States 97301
    37 Site 717 Media Pennsylvania United States 19063
    38 Site 731 Philadelphia Pennsylvania United States 19107
    39 Site 742 Lincoln Rhode Island United States 02865
    40 Site 710 Anderson South Carolina United States 29621
    41 Site 724 Chattanooga Tennessee United States 37421
    42 Site 719 Austin Texas United States 78731
    43 Site 702 Plano Texas United States 75024
    44 Site 714 Virginia Beach Virginia United States 23454
    45 Site 722 Bellevue Washington United States 98007

    Sponsors and Collaborators

    • BioDelivery Sciences International

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BioDelivery Sciences International
    ClinicalTrials.gov Identifier:
    NCT03006276
    Other Study ID Numbers:
    • DFN-15-CD-007
    First Posted:
    Dec 30, 2016
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Migraine Disorders
    Headache
    Celecoxib

    Study Results

    No Results Posted as of Nov 17, 2021