Back to resultsEfficacy, Tolerability, and Safety Study of DFN-15
Primary Purpose
Migraine Headache
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DFN-15 Active
DFN-15 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Headache
Eligibility Criteria
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.
Sites / Locations
- Site 744
- Site 727
- Site 723
- Site 718
- Site 709
- Site 708
- Site 729
- Site 725
- Site 738
- Site 733
- Site 726
- Site 735
- Site 711
- Site 721
- Site 740
- Site 720
- Site 734
- Site 739
- Site 713
- Site 706
- Site 712
- Site 703
- Site 730
- Site 704
- Site 736
- Site 737
- Site 745
- Site 716
- Site 746
- Site 705
- Site 743
- Site 715
- Site 728
- Site 707
- Site 701
- Site 741
- Site 717
- Site 731
- Site 742
- Site 710
- Site 724
- Site 719
- Site 702
- Site 714
- Site 722
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DFN-15 Active
DFN-15 Placebo
Arm Description
DFN-15 Active
DFN-15 Placebo
Outcomes
Primary Outcome Measures
Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (DB1)
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.
Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose (DB1)
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
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 during each DB treatment period were summarized by symptom, treatment group, and time point.
Time to Headache Pain Relief Postdose (DB1 and DB2)
Time to Headache Pain Freedom Postdose (DB1 and DB2)
Headache Pain Relief Postdose (DB1 and DB2)
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.
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), and 4, and 24 hours postdose during each DB treatment period were summarized by treatment group.
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
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.
Change in Functional Disability Score Postdose (DB1 and DB2)
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.
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 during each DB treatment period among those subjects reporting cutaneous allodynia before dosing were summarized by treatment group and time point.
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 during each DB treatment period were summarized by treatment group and time point.
Headache Pain Recurrence Postdose (DB1 and DB2)
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.
Sustained Headache Pain Relief Postdose (DB1 and DB2)
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.
Sustained Headache Pain Freedom Postdose (DB1 and DB2)
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.
Use of Rescue Medication Postdose (DB1 and DB2)
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.
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.
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.
Full Information
NCT ID
NCT03006276
First Posted
December 27, 2016
Last Updated
December 15, 2022
Sponsor
BioDelivery Sciences International
1. Study Identification
Unique Protocol Identification Number
NCT03006276
Brief Title
Efficacy, Tolerability, and Safety Study of DFN-15
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 Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioDelivery Sciences International
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
622 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DFN-15 Active
Arm Type
Experimental
Arm Description
DFN-15 Active
Arm Title
DFN-15 Placebo
Arm Type
Placebo Comparator
Arm Description
DFN-15 Placebo
Intervention Type
Drug
Intervention Name(s)
DFN-15 Active
Other Intervention Name(s)
Celecoxib Oral Solution
Intervention Type
Other
Intervention Name(s)
DFN-15 Placebo
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (DB1)
Description
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.
Time Frame
2 hours post dose
Title
Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose (DB1)
Description
Percentage of subjects who are free from their most bothersome symptom (MBS) among nausea, photophobia, and phonophobia at 2 hours postdose during DB1.
Time Frame
2 hours post dose
Secondary Outcome Measure Information:
Title
Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
Description
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.
Time Frame
15 minutes through 24 hours
Title
Time to Headache Pain Relief Postdose (DB1 and DB2)
Time Frame
2 hours postdose
Title
Time to Headache Pain Freedom Postdose (DB1 and DB2)
Time Frame
2 hours postdose
Title
Headache Pain Relief Postdose (DB1 and DB2)
Description
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.
Time Frame
15 minutes to 24 hours postdose
Title
Headache Pain Freedom Postdose (DB1 and DB2)
Description
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.
Time Frame
15 minutes to 24 hours postdose
Title
Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
Description
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.
Time Frame
15 minutes to 24 hours postdose
Title
Change in Functional Disability Score Postdose (DB1 and DB2)
Description
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.
Time Frame
2 to 24 hours postdose
Title
Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2)
Description
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.
Time Frame
2 to 4 hours postdose
Title
Headache Pain Freedom Among BMI Category (DB1 and DB2)
Description
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.
Time Frame
2 to 4 hours postdose
Title
Headache Pain Recurrence Postdose (DB1 and DB2)
Description
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.
Time Frame
2 to 24 hours postdose
Title
Sustained Headache Pain Relief Postdose (DB1 and DB2)
Description
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.
Time Frame
2 to 24 hours postdose
Title
Sustained Headache Pain Freedom Postdose (DB1 and DB2)
Description
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.
Time Frame
2 to 24 hours postdose
Title
Use of Rescue Medication Postdose (DB1 and DB2)
Description
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.
Time Frame
2 to 24 hours postdose
Title
Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2)
Description
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.
Time Frame
2 to 4 hours postdose
Title
Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
Description
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.
Time Frame
24 hours postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Site 744
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Site 727
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Site 723
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Site 718
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Site 709
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Site 708
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Site 729
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Site 725
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Site 738
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Site 733
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Site 726
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Site 735
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Site 711
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Site 721
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Site 740
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Site 720
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Site 734
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Site 739
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Site 713
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Site 706
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Site 712
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Site 703
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Site 730
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Site 704
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Site 736
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Site 737
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Site 745
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
Site 716
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Site 746
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Site 705
City
Manhattan
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Site 743
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Site 715
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Site 728
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Site 707
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Site 701
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Site 741
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Site 717
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Site 731
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Site 742
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Site 710
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Site 724
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Site 719
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Site 702
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Site 714
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Site 722
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/31647577/
Description
Publication of study results
Learn more about this trial
Efficacy, Tolerability, and Safety Study of DFN-15
We'll reach out to this number within 24 hrs