A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Tolerability, and Safety Study of DFN-15 in Episodic Migraine With or Without Aura

ClinicalTrials.gov processed this data on December 15, 2022. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
 (See Contacts and Locations)
Verified December 2022 by BioDelivery Sciences International

Sponsor

BioDelivery Sciences International

Information Provided by (Responsible Party)

BioDelivery Sciences International

Clinicaltrials.gov Identifier

NCT03006276
Other Study ID Numbers: DFN-15-CD-007
First Submitted: December 27, 2016
First Posted: December 30, 2016
Results First Posted: January 10, 2023
Last Update Posted: January 10, 2023
Last Verified: December 2022
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Migraine Headache
  • Drug: DFN-15 Active
  • Other: DFN-15 Placebo

Study Design

Study TypeInterventional
Actual Enrollment622 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Tolerability, and Safety Study of DFN-15 in Episodic Migraine With or Without Aura
Study Start DateDecember 2016
Actual Primary Completion DateNovember 2017
Actual Study Completion DateMay 2019

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • DFN-15 Active
    • DFN-15 Active
  • Drug: DFN-15 Active
    • DFN-15 Placebo
      • DFN-15 Placebo
    • Other: DFN-15 Placebo

      Outcome Measures

      Primary Outcome Measures

      1. Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (DB1) [2 hours post dose]
        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. Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose (DB1) [2 hours post dose]
        Percentage of subjects who are free from their most bothersome symptom (MBS) among nausea, photophobia, and phonophobia at 2 hours postdose during DB1.

      Secondary Outcome Measures

      1. Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2) [15 minutes through 24 hours]
        The percentage of subjects who were free from nausea, photophobia, and phonophobia at 15, 30, and 45 minutes and 1, 1.5, 2, 4, and 24 hours postdose during each DB treatment period were summarized by symptom, treatment group, and time point.
      2. Time to Headache Pain Relief Postdose (DB1 and DB2) [2 hours postdose]
      3. Time to Headache Pain Freedom Postdose (DB1 and DB2) [2 hours postdose]
      4. Headache Pain Relief Postdose (DB1 and DB2) [15 minutes to 24 hours postdose]
        Headache pain relief during postdose in DB1 was defined as a reduction from moderate or severe pain at predose reduced to mild or none postdose, and for DB2 as moderate or severe pain at predose reduced to mild or none postdose, or mild pain at predose reduced to none postdose. Outcome measure shows percentage of subjects experiencing headache pain relief by time point.
      5. Headache Pain Freedom Postdose (DB1 and DB2) [15 minutes to 24 hours postdose]
        The percentage of subjects who were pain-free at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2), and 4, and 24 hours postdose during each DB treatment period were summarized by treatment group.
      6. Absence of Screening MBS at Time Points Postdose (DB1 and DB2) [15 minutes to 24 hours postdose]
        The percentage of subjects with their Screening MBS (most bothersome symptoms) among nausea, photophobia, and phonophobia (from eDiary data collection) absent at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose during each DB treatment period were summarized by treatment group and time point.
      7. Change in Functional Disability Score Postdose (DB1 and DB2) [2 to 24 hours postdose]
        The values of the functional disability scale were: 0=no disability, able to function normally; 1=performance of daily activities mildly impaired, can still do everything but with difficulty; 2=performance of daily activities moderately impaired, unable to do some things; 3=performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary.

        A decrease in values indicates improvement from baseline.
      8. Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2) [2 to 4 hours postdose]
        The percentage of subjects who were pain-free at 2 and 4 hours postdose during each DB treatment period among those subjects reporting cutaneous allodynia before dosing were summarized by treatment group and time point.
      9. Headache Pain Freedom Among BMI Category (DB1 and DB2) [2 to 4 hours postdose]
        The percentage of subjects who were pain-free at 2 and 4 hours postdose whose BMI was <30 kg/m2 vs. subjects whose BMI was ≥30 kg/m2 during each DB treatment period were summarized by treatment group and time point.
      10. Headache Pain Recurrence Postdose (DB1 and DB2) [2 to 24 hours postdose]
        Headache pain recurrence was defined as pain-free at 2 hours postdose with pain reported as mild, moderate, or severe at 24 hours postdose. This outcome measure shows percentage of subjects who reported pain-free status and 2 hours postdose but subsequently reported recurrent pain at 24 hours postdose.
      11. Sustained Headache Pain Relief Postdose (DB1 and DB2) [2 to 24 hours postdose]
        Sustained headache pain relief was defined as pain relief at 2 hours postdose with no use of rescue medication and no worsening of headache pain within 2 to 24 hours postdose. This outcome measure shows the percentage of subjects who reported pain relief at 2 hours postdose with no use of rescue medication or worsening of headache pain through 24 hours postdose.
      12. Sustained Headache Pain Freedom Postdose (DB1 and DB2) [2 to 24 hours postdose]
        Sustained headache pain freedom was defined as pain-free at 2 hours postdose, with no use of rescue medication and no recurrence of headache pain within 2 to 24 hours postdose. This outcome measure shows percentage of subjects who were pain-free at 2 hours postdose without the use of rescue medication or recurrence of headache pain through 24 hours postdose.
      13. Use of Rescue Medication Postdose (DB1 and DB2) [2 to 24 hours postdose]
        The percentage of subjects who used rescue mediation after 2 hours (2 to 24 hours) postdose compared between DFN-15 and placebo in each DB period.
      14. Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2) [2 to 4 hours postdose]
        Subject-rated treatment overall satisfaction was based on a 7-point scale at 2 and 4 hours postdose during each DB treatment period. The difference between the subject-rated study drug treatment satisfaction score at 2 and 4 hours postdose and the baseline PPMQ-R (Patient Perception of Migraine Questionnaire) response for the same question were summarized by treatment group (global satisfaction item at baseline asked about the subject's usual migraine treatment). The possible values of the subject treatment satisfaction scale were: 1=very satisfied, 2=satisfied, 3=somewhat satisfied, 4=neither satisfied nor dissatisfied, 5=somewhat dissatisfied, 6=dissatisfied, 7=very dissatisfied.

        A decrease in values indicates improvement from baseline.
      15. Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2) [24 hours postdose]
        Patient Perception of Migraine Questionnaire-Revised had 30 questions assessing subject's satisfaction with migraine medication, including 3 global items & 4 subscales (i.e., efficacy, function, ease of use, tolerability). A 5-point scale (1-Not At All to 5-Extremely) was used for tolerability subscale questions; a 7-point scale (1-Very Satisfied to 7-Very Dissatisfied) was used for all other subscales and global items. Total score was average of efficacy/function/ease of use subscale scores. Each subscale & total scores were transformed to range from 0-100, with higher scores indicating better satisfaction or tolerability. Total raw score/global items were not transformed. The total raw score could range from 17 (min) to 119 (max), with lower scores indicating better satisfaction. Change from baseline scores at 24-hour-postdose for each subscale score, global item score, total score, & total raw score were summarized by treatment group below.

      Eligibility Criteria

      Ages Eligible for Study 18 Years to 75 Years (Adult, Older Adult)
      Sexes Eligible for Study All
      Accepts Healthy Volunteers No
      Inclusion Criteria
      • 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.
      Exclusion Criteria
      • 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.

      Contacts and Locations

      Sponsors and Collaborators BioDelivery Sciences International
      Locations
      • Site 744 | Birmingham, Alabama, United States, 35216
      • Site 727 | Phoenix, Arizona, United States, 85018
      • Site 723 | Little Rock, Arkansas, United States, 72211
      • Site 718 | Rogers, Arkansas, United States, 72758
      • Site 709 | Los Angeles, California, United States, 90017
      • Site 708 | Orange, California, United States, 92868
      • Site 729 | San Diego, California, United States, 92103
      • Site 725 | Santa Monica, California, United States, 90404
      • Site 738 | Simi Valley, California, United States, 93065
      • Site 733 | Upland, California, United States, 91786
      • Site 726 | Colorado Springs, Colorado, United States, 80907
      • Site 735 | DeLand, Florida, United States, 32720
      • Site 711 | Hialeah, Florida, United States, 33016
      • Site 721 | Jacksonville, Florida, United States, 32256
      • Site 740 | Blue Ridge, Georgia, United States, 30513
      • Site 720 | Decatur, Georgia, United States, 30030
      • Site 734 | West Des Moines, Iowa, United States, 50265
      • Site 739 | Prairie Village, Kansas, United States, 66208
      • Site 713 | Wichita, Kansas, United States, 67205
      • Site 706 | Shreveport, Louisiana, United States, 71105
      • Site 712 | Baltimore, Maryland, United States, 21236
      • Site 703 | Boston, Massachusetts, United States, 02131
      • Site 730 | New Bedford, Massachusetts, United States, 02740
      • Site 704 | Minneapolis, Minnesota, United States, 55402
      • Site 736 | Hazelwood, Missouri, United States, 63042
      • Site 737 | Springfield, Missouri, United States, 65807
      • Site 745 | Las Vegas, Nevada, United States, 89103
      • Site 716 | Berlin, New Jersey, United States, 08009
      • Site 746 | Amherst, New York, United States, 14226
      • Site 705 | Manhattan, New York, United States, 10018
      • Site 743 | Williamsville, New York, United States, 14221
      • Site 715 | Raleigh, North Carolina, United States, 27612
      • Site 728 | Cincinnati, Ohio, United States, 45255
      • Site 707 | Dayton, Ohio, United States, 45424
      • Site 701 | Oklahoma City, Oklahoma, United States, 73103
      • Site 741 | Salem, Oregon, United States, 97301
      • Site 717 | Media, Pennsylvania, United States, 19063
      • Site 731 | Philadelphia, Pennsylvania, United States, 19107
      • Site 742 | Lincoln, Rhode Island, United States, 02865
      • Site 710 | Anderson, South Carolina, United States, 29621
      • Site 724 | Chattanooga, Tennessee, United States, 37421
      • Site 719 | Austin, Texas, United States, 78731
      • Site 702 | Plano, Texas, United States, 75024
      • Site 714 | Virginia Beach, Virginia, United States, 23454
      • Site 722 | Bellevue, Washington, United States, 98007

      Study Documents (Full Text)

      More Information

      Additional Information

      Additional Relevant MeSH Terms

      • Migraine Disorders
      • Headache
      • Headache Disorders, Primary
      • Headache Disorders
      • Brain Diseases
      • Central Nervous System Diseases
      • Nervous System Diseases
      • Pain
      • Neurologic Manifestations