Efficacy, Tolerability, and Safety Study of DFN-15

Migraine Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006276
• Other study ID #: DFN-15-CD-007
• Status: Completed
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: May 2019

Study information

• Verified date: December 2022
• Source: BioDelivery Sciences International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 622
• Est. completion date: May 2019
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• DFN-15 Active

Other:
• DFN-15 Placebo

Locations

Country	Name	City	State
United States	Site 746	Amherst	New York
United States	Site 710	Anderson	South Carolina
United States	Site 719	Austin	Texas
United States	Site 712	Baltimore	Maryland
United States	Site 722	Bellevue	Washington
United States	Site 716	Berlin	New Jersey
United States	Site 744	Birmingham	Alabama
United States	Site 740	Blue Ridge	Georgia
United States	Site 703	Boston	Massachusetts
United States	Site 724	Chattanooga	Tennessee
United States	Site 728	Cincinnati	Ohio
United States	Site 726	Colorado Springs	Colorado
United States	Site 707	Dayton	Ohio
United States	Site 720	Decatur	Georgia
United States	Site 735	DeLand	Florida
United States	Site 736	Hazelwood	Missouri
United States	Site 711	Hialeah	Florida
United States	Site 721	Jacksonville	Florida
United States	Site 745	Las Vegas	Nevada
United States	Site 742	Lincoln	Rhode Island
United States	Site 723	Little Rock	Arkansas
United States	Site 709	Los Angeles	California
United States	Site 705	Manhattan	New York
United States	Site 717	Media	Pennsylvania
United States	Site 704	Minneapolis	Minnesota
United States	Site 730	New Bedford	Massachusetts
United States	Site 701	Oklahoma City	Oklahoma
United States	Site 708	Orange	California
United States	Site 731	Philadelphia	Pennsylvania
United States	Site 727	Phoenix	Arizona
United States	Site 702	Plano	Texas
United States	Site 739	Prairie Village	Kansas
United States	Site 715	Raleigh	North Carolina
United States	Site 718	Rogers	Arkansas
United States	Site 741	Salem	Oregon
United States	Site 729	San Diego	California
United States	Site 725	Santa Monica	California
United States	Site 706	Shreveport	Louisiana
United States	Site 738	Simi Valley	California
United States	Site 737	Springfield	Missouri
United States	Site 733	Upland	California
United States	Site 714	Virginia Beach	Virginia
United States	Site 734	West Des Moines	Iowa
United States	Site 713	Wichita	Kansas
United States	Site 743	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
BioDelivery Sciences International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 hours post dose
Primary	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.	2 hours post dose
Secondary	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.	15 minutes through 24 hours
Secondary	Time to Headache Pain Relief Postdose (DB1 and DB2)		2 hours postdose
Secondary	Time to Headache Pain Freedom Postdose (DB1 and DB2)		2 hours postdose
Secondary	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.	15 minutes to 24 hours postdose
Secondary	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.	15 minutes to 24 hours postdose
Secondary	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.	15 minutes to 24 hours postdose
Secondary	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.	2 to 24 hours postdose
Secondary	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.	2 to 4 hours postdose
Secondary	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.	2 to 4 hours postdose
Secondary	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.	2 to 24 hours postdose
Secondary	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.	2 to 24 hours postdose
Secondary	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.	2 to 24 hours postdose
Secondary	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.	2 to 24 hours postdose
Secondary	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.	2 to 4 hours postdose
Secondary	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.	24 hours postdose

External Links

•   Publication of study results