Efficacy, Tolerability, and Safety of DFN-15

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified November 2022 by BioDelivery Sciences International
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 26, 2016
First Posted
January 3, 2017
Results First Posted
April 21, 2022
Last Update Posted
January 9, 2023
Last Verified
November 2022

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

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Migraine Headache
Drug: DFN-15 ActiveOther: 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 DateNovember 30, 2016
Actual Primary Completion DateOctober 31, 2017
Actual Study Completion DateApril 30, 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)
    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
    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
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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)
    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(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsBioDelivery Sciences International
Locations
Site 609 | Birmingham Alabama, United States, 35205Site 640 | Mobile Alabama, United States, 36608Site 622 | Tucson Arizona, United States, 85745Site 616 | Hot Springs Arkansas, United States, 71901Site 637 | Huntington Beach California, United States, 92647Site 615 | Oakland California, United States, 94607Site 646 | San Diego California, United States, 92108Site 619 | San Francisco California, United States, 94102Site 624 | San Marcos California, United States, 92078Site 631 | Littleton Colorado, United States, 80127Site 603 | Miami Florida, United States, 33176Site 641 | Orange City Florida, United States, 32763Site 629 | Orlando Florida, United States, 32801Site 601 | West Palm Beach Florida, United States, 33409Site 625 | Decatur Georgia, United States, 30034Site 630 | Sandy Springs Georgia, United States, 30328Site 642 | Meridian Idaho, United States, 83642Site 604 | Blue Island Illinois, United States, 60406Site 602 | Louisville Kentucky, United States, 40213Site 644 | New Orleans Louisiana, United States, 70115Site 610 | New Orleans Louisiana, United States, 70124Site 634 | Ann Arbor Michigan, United States, 48104Site 623 | Edina Minnesota, United States, 55435Site 638 | City of Saint Peters Missouri, United States, 63303Site 606 | Missoula Montana, United States, 59808Site 613 | Omaha Nebraska, United States, 68134Site 647 | Lebanon New Hampshire, United States, 03756Site 618 | Nashua New Hampshire, United States, 03060Site 636 | Albuquerque New Mexico, United States, 87102Site 645 | Brooklyn New York, United States, 11229Site 608 | Rochester New York, United States, 14609Site 620 | High Point North Carolina, United States, 27262Site 643 | Mooresville North Carolina, United States, 28117Site 626 | Fargo North Dakota, United States, 58103Site 628 | Cleveland Ohio, United States, 44122Site 614 | Warwick Rhode Island, United States, 02886Site 639 | Mt. Pleasant South Carolina, United States, 29464Site 612 | Dakota Dunes South Dakota, United States, 57049Site 627 | Austin Texas, United States, 78745Site 611 | Dallas Texas, United States, 75231Site 632 | San Antonio Texas, United States, 78240Site 621 | Taylorsville Utah, United States, 84123Site 635 | Richmond Virginia, United States, 23294
Study Documents (Full Text)
Documents provided by BioDelivery Sciences International: Study Protocol  May 8, 2017Documents provided by BioDelivery Sciences International: Statistical Analysis Plan  November 7, 2017