Efficacy, Tolerability, and Safety of DFN-15

December 15, 2022 updated by: BioDelivery Sciences International

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

Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

631

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Site 609
      • Mobile, Alabama, United States, 36608
        • Site 640
    • Arizona
      • Tucson, Arizona, United States, 85745
        • Site 622
    • Arkansas
      • Hot Springs, Arkansas, United States, 71901
        • Site 616
    • California
      • Huntington Beach, California, United States, 92647
        • Site 637
      • Oakland, California, United States, 94607
        • Site 615
      • San Diego, California, United States, 92108
        • Site 646
      • San Francisco, California, United States, 94102
        • Site 619
      • San Marcos, California, United States, 92078
        • Site 624
    • Colorado
      • Littleton, Colorado, United States, 80127
        • Site 631
    • Florida
      • Miami, Florida, United States, 33176
        • Site 603
      • Orange City, Florida, United States, 32763
        • Site 641
      • Orlando, Florida, United States, 32801
        • Site 629
      • West Palm Beach, Florida, United States, 33409
        • Site 601
    • Georgia
      • Decatur, Georgia, United States, 30034
        • Site 625
      • Sandy Springs, Georgia, United States, 30328
        • Site 630
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Site 642
    • Illinois
      • Blue Island, Illinois, United States, 60406
        • Site 604
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Site 602
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Site 644
      • New Orleans, Louisiana, United States, 70124
        • Site 610
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Site 634
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Site 623
    • Missouri
      • Saint Peters, Missouri, United States, 63303
        • Site 638
    • Montana
      • Missoula, Montana, United States, 59808
        • Site 606
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Site 613
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Site 647
      • Nashua, New Hampshire, United States, 03060
        • Site 618
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Site 636
    • New York
      • Brooklyn, New York, United States, 11229
        • Site 645
      • Rochester, New York, United States, 14609
        • Site 608
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Site 620
      • Mooresville, North Carolina, United States, 28117
        • Site 643
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Site 626
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Site 628
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Site 614
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Site 639
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Site 612
    • Texas
      • Austin, Texas, United States, 78745
        • Site 627
      • Dallas, Texas, United States, 75231
        • Site 611
      • San Antonio, Texas, United States, 78240
        • Site 632
    • Utah
      • Taylorsville, Utah, United States, 84123
        • Site 621
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Site 635

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DFN-15 Active
Other Names:
  • Celecoxib Oral Solution
Placebo Comparator: DFN-15 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (First Treated Double-blind Treatment Period)
Time Frame: 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 hours postdose
Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose
Time Frame: 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)
2 hours postdose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Subjects With TEAEs After Study Drug Compared Between DFN-15 and Placebo
Time Frame: 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.

Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
Time Frame: 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
15 minutes to 24 hours postdose
Time to Headache Pain Relief Postdose (DB1 and DB2)
Time Frame: 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.
2 hours postdose
Time to Headache Pain Freedom Postdose (DB1 and DB2)
Time Frame: 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.
2 hours postdose
Headache Pain Relief Postdose (DB1 and DB2)
Time Frame: 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.
15 minutes to 24 hours postdose
Headache Pain Freedom Postdose (DB1 and DB2)
Time Frame: 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
15 minutes to 24 hours postdose
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
Time Frame: 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.
15 minutes to 24 hours postdose
Change in Functional Disability Score Postdose (DB1 and DB2)
Time Frame: 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.

2 to 24 hours postdose
Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2)
Time Frame: 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
2 and 4 hours postdose
Headache Pain Freedom Among BMI Category (DB1 and DB2)
Time Frame: 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
2 and 4 hours postdose
Headache Pain Recurrence Postdose (DB1 and DB2)
Time Frame: 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
2 to 24 hours postdose
Sustained Headache Pain Relief Postdose (DB1 and DB2)
Time Frame: 2 to 24 hours postdose
The percentage of the population of subjects who reported headache pain relief between 2 and 24 hours postdose.
2 to 24 hours postdose
Sustained Headache Pain Freedom Postdose (DB1 and DB2)
Time Frame: 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
2 to 24 hours postdose
Use of Rescue Medication Postdose (DB1 and DB2)
Time Frame: 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
2 to 24 hours postdose
Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2)
Time Frame: 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.

2 and 4 hours postdose
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Time Frame: 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.
24 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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