Loading clinical trials...

Efficacy, Tolerability, and Safety of DFN-15 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy, Tolerability, and Safety of DFN-15

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

NCT03009019•BioDelivery Sciences International

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (43)

Site 609

Birmingham, Alabama, United States

Site 640

Mobile, Alabama, United States

Site 622

Tucson, Arizona, United States

Site 616

Hot Springs, Arkansas, United States

Site 637

Huntington Beach, California, United States

Site 615

Oakland, California, United States

Site 646

San Diego, California, United States

Site 619

San Francisco, California, United States

Site 624

San Marcos, California, United States

Site 631

Littleton, Colorado, United States

Key Dates

Start Date

December 1, 2016

Primary Completion Date

November 1, 2017

Completion Date

May 1, 2019

Last Updated

January 10, 2023

Enrollment

631

ACTUAL participants

Conditions

Migraine Headache

Interventions

DFN-15 Active

DRUG

DFN-15 Placebo

OTHER

Light Exposure, Migraine Outcomes, and Sleep Quality

NCT07476053

Migraine HeadacheSleep+1 more

View study

RECRUITINGNA

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

NCT06203873

PFO - Patent Foramen OvaleMigraine+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy, Tolerability, and Safety of DFN-15

Inclusion Criteria

Exclusion Criteria

Light Exposure, Migraine Outcomes, and Sleep Quality

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

Vitamin K2 Supplementation in Adult Episodic Migraine

Neurostimulation Device for Treatment of Migraine Headache

Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)

A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack