Back to resultsEfficacy, Tolerability, and Safety 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 609
- Site 640
- Site 622
- Site 616
- Site 637
- Site 615
- Site 646
- Site 619
- Site 624
- Site 631
- Site 603
- Site 641
- Site 629
- Site 601
- Site 625
- Site 630
- Site 642
- Site 604
- Site 602
- Site 644
- Site 610
- Site 634
- Site 623
- Site 638
- Site 606
- Site 613
- Site 647
- Site 618
- Site 636
- Site 645
- Site 608
- Site 620
- Site 643
- Site 626
- Site 628
- Site 614
- Site 639
- Site 612
- Site 627
- Site 611
- Site 632
- Site 621
- Site 635
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 (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]
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
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.
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
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.
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.
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.
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
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.
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.
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
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
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
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.
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
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
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
NCT03009019
First Posted
December 27, 2016
Last Updated
December 15, 2022
Sponsor
BioDelivery Sciences International
Collaborators
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT03009019
Brief Title
Efficacy, Tolerability, and Safety 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
Collaborators
Dr. Reddy's Laboratories Limited
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
631 (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 (First Treated Double-blind Treatment Period)
Description
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]
Time Frame
2 hours postdose
Title
Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose
Description
Percentage of subjects who are free from their Most Bothersome Symptom (MBS) among nausea, photophobia, and phonophobia (first double-blind treatment period)
Time Frame
2 hours postdose
Secondary Outcome Measure Information:
Title
The Number of Subjects With TEAEs After Study Drug Compared Between DFN-15 and Placebo
Description
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.
Time Frame
Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
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 compared between DFN-15 and placebo
Time Frame
15 minutes to 24 hours postdose
Title
Time to Headache Pain Relief Postdose (DB1 and DB2)
Description
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.
Time Frame
2 hours postdose
Title
Time to Headache Pain Freedom Postdose (DB1 and DB2)
Description
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.
Time Frame
2 hours postdose
Title
Headache Pain Relief Postdose (DB1 and DB2)
Description
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.
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 period), 4, and 24 hours postdose compared between DFN-15 and placebo
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 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.
Time Frame
15 minutes to 24 hours postdose
Title
Change in Functional Disability Score Postdose (DB1 and DB2)
Description
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.
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 compared between DFN-15 and placebo, among those reporting cutaneous allodynia predose
Time Frame
2 and 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, and whose BMI was < 25 kg/m2 vs. subjects whose BMI was ≥ 25 kg/m2
Time Frame
2 and 4 hours postdose
Title
Headache Pain Recurrence Postdose (DB1 and DB2)
Description
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
Time Frame
2 to 24 hours postdose
Title
Sustained Headache Pain Relief Postdose (DB1 and DB2)
Description
The percentage of the population of subjects who reported headache pain relief between 2 and 24 hours postdose.
Time Frame
2 to 24 hours postdose
Title
Sustained Headache Pain Freedom Postdose (DB1 and DB2)
Description
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
Time Frame
2 to 24 hours postdose
Title
Use of Rescue Medication Postdose (DB1 and DB2)
Description
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
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 and 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 609
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Site 640
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Site 622
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Site 616
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71901
Country
United States
Facility Name
Site 637
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Site 615
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Site 646
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Site 619
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Site 624
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Site 631
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80127
Country
United States
Facility Name
Site 603
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Site 641
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Site 629
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Site 601
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Site 625
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Site 630
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Site 642
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Site 604
City
Blue Island
State/Province
Illinois
ZIP/Postal Code
60406
Country
United States
Facility Name
Site 602
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Site 644
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Site 610
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
Site 634
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Site 623
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Site 638
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Site 606
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Site 613
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Site 647
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Site 618
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Site 636
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Site 645
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Site 608
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Site 620
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Site 643
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Site 626
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Site 628
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Site 614
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Site 639
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Site 612
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
Site 627
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Site 611
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site 632
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Site 621
City
Taylorsville
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Site 635
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34447267
Citation
Lipton RB, Munjal S, Tepper SJ, Iaconangelo C, Serrano D. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Tolerability, and Safety of Celecoxib Oral Solution (ELYXYB) in Acute Treatment of Episodic Migraine with or without Aura. J Pain Res. 2021 Aug 19;14:2529-2542. doi: 10.2147/JPR.S322292. eCollection 2021.
Results Reference
derived
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/34447267/
Description
Publication of study results
Learn more about this trial
Efficacy, Tolerability, and Safety of DFN-15
We'll reach out to this number within 24 hrs