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, Dr. Reddy's Laboratories Limited

Sponsor

BioDelivery Sciences International

Information Provided by (Responsible Party)

BioDelivery Sciences International

Clinicaltrials.gov Identifier

NCT03009019
Other Study ID Numbers: DFN-15-CD-006
First Submitted: December 27, 2016
First Posted: January 4, 2017
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 Enrollment631 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 (First Treated Double-blind Treatment Period) [2 hours postdose]
        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. Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose [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)

      Secondary Outcome Measures

      1. 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.]
        For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first.

        For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2.
      2. Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2) [15 minutes to 24 hours postdose]
        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 compared between DFN-15 and placebo
      3. Time to Headache Pain Relief Postdose (DB1 and DB2) [2 hours postdose]
        The time to headache pain relief was defined as the time in minutes from when a subject took study drug until the time pain relief was indicated by the subject in the eDiary within 2 hours postdose.
      4. Time to Headache Pain Freedom Postdose (DB1 and DB2) [2 hours postdose]
        The time to headache pain freedom was defined as the time in minutes from when a subject took study drug until the time pain freedom was indicated by the subject in the eDiary within 2 hours postdose.
      5. Headache Pain Relief Postdose (DB1 and DB2) [15 minutes to 24 hours postdose]
        Headache pain relief was defined for DB1 as a reduction from moderate or severe pain before dosing to mild or none postdose, and for DB2 as moderate or severe pain before dosing reduced to mild or none postdose, or mild pain before dosing reduced to none postdose. Data are reported by percentage reporting headache pain relief over time postdose.
      6. 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 period), 4, and 24 hours postdose compared between DFN-15 and placebo
      7. 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 Symptom) absent at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose compared between DFN-15 and placebo.
      8. Change in Functional Disability Score Postdose (DB1 and DB2) [2 to 24 hours postdose]
        Change in functional disability score at 2, 4, and 24 hours postdose compared between DFN-15 and placebo. 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.
      9. Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2) [2 and 4 hours postdose]
        The percentage of subjects who were pain-free at 2 and 4 hours postdose compared between DFN-15 and placebo, among those reporting cutaneous allodynia predose
      10. Headache Pain Freedom Among BMI Category (DB1 and DB2) [2 and 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, and whose BMI was < 25 kg/m2 vs. subjects whose BMI was ≥ 25 kg/m2
      11. Headache Pain Recurrence Postdose (DB1 and DB2) [2 to 24 hours postdose]
        The percentage of subjects who had pain recurrence between 2 to 24 hours (i.e., pain-free at 2 hours postdose, with pain [mild, moderate, or severe] reported at 24 hours postdose) compared between DFN-15 and placebo
      12. Sustained Headache Pain Relief Postdose (DB1 and DB2) [2 to 24 hours postdose]
        The percentage of the population of subjects who reported headache pain relief between 2 and 24 hours postdose.
      13. Sustained Headache Pain Freedom Postdose (DB1 and DB2) [2 to 24 hours postdose]
        The percentage of subjects who had sustained pain freedom at 2 to 24 hours postdose compared between DFN-15 and placebo in each DB period. Sustained pain freedom at 2 to 24 hours postdose is 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
      14. Use of Rescue Medication Postdose (DB1 and DB2) [2 to 24 hours postdose]
        The percentage of subjects who used rescue medication after 2 hours (2 to 24 hours) postdose compared between DFN-15 and placebo in each DB period
      15. Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2) [2 and 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.
      16. 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, Dr. Reddy's Laboratories Limited
      Dr. Reddy's Laboratories Limited
      Locations
      • Site 609 | Birmingham, Alabama, United States, 35205
      • Site 640 | Mobile, Alabama, United States, 36608
      • Site 622 | Tucson, Arizona, United States, 85745
      • Site 616 | Hot Springs, Arkansas, United States, 71901
      • Site 637 | Huntington Beach, California, United States, 92647
      • Site 615 | Oakland, California, United States, 94607
      • Site 646 | San Diego, California, United States, 92108
      • Site 619 | San Francisco, California, United States, 94102
      • Site 624 | San Marcos, California, United States, 92078
      • Site 631 | Littleton, Colorado, United States, 80127
      • Site 603 | Miami, Florida, United States, 33176
      • Site 641 | Orange City, Florida, United States, 32763
      • Site 629 | Orlando, Florida, United States, 32801
      • Site 601 | West Palm Beach, Florida, United States, 33409
      • Site 625 | Decatur, Georgia, United States, 30034
      • Site 630 | Sandy Springs, Georgia, United States, 30328
      • Site 642 | Meridian, Idaho, United States, 83642
      • Site 604 | Blue Island, Illinois, United States, 60406
      • Site 602 | Louisville, Kentucky, United States, 40213
      • Site 644 | New Orleans, Louisiana, United States, 70115
      • Site 610 | New Orleans, Louisiana, United States, 70124
      • Site 634 | Ann Arbor, Michigan, United States, 48104
      • Site 623 | Edina, Minnesota, United States, 55435
      • Site 638 | Saint Peters, Missouri, United States, 63303
      • Site 606 | Missoula, Montana, United States, 59808
      • Site 613 | Omaha, Nebraska, United States, 68134
      • Site 647 | Lebanon, New Hampshire, United States, 03756
      • Site 618 | Nashua, New Hampshire, United States, 03060
      • Site 636 | Albuquerque, New Mexico, United States, 87102
      • Site 645 | Brooklyn, New York, United States, 11229
      • Site 608 | Rochester, New York, United States, 14609
      • Site 620 | High Point, North Carolina, United States, 27262
      • Site 643 | Mooresville, North Carolina, United States, 28117
      • Site 626 | Fargo, North Dakota, United States, 58103
      • Site 628 | Cleveland, Ohio, United States, 44122
      • Site 614 | Warwick, Rhode Island, United States, 02886
      • Site 639 | Mount Pleasant, South Carolina, United States, 29464
      • Site 612 | Dakota Dunes, South Dakota, United States, 57049
      • Site 627 | Austin, Texas, United States, 78745
      • Site 611 | Dallas, Texas, United States, 75231
      • Site 632 | San Antonio, Texas, United States, 78240
      • Site 621 | Taylorsville, Utah, United States, 84123
      • Site 635 | Richmond, Virginia, United States, 23294

      Study Documents (Full Text)

      More Information

      Additional Information

      Publications

      Additional Relevant MeSH Terms

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