Two Dose Levels of DFN-15 vs. Placebo in Patients With Migraine Headaches
A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study Evaluating Efficacy of DFN-15 in Patients With Migraine Headache With or Without Aura
1 other identifier
interventional
63
1 country
6
Brief Summary
Crossover study of DFN-15 dose A versus DFN-15 dose B versus Placebo in the treatment of migraine headaches.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2015
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2015
CompletedFirst Submitted
Initial submission to the registry
June 8, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2016
CompletedMay 22, 2018
April 1, 2018
6 months
June 8, 2015
May 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Pain Free, defined as a score of "0" on a numerical scale of "0" to "3"
Percentage of subjects who are migraine headache free at 2 hours after taking study drug administration
2 hour
Study Arms (3)
DFN-15 120 mg (treatment A)
EXPERIMENTALDFN-15 120 mg (treatment A)
DFN-15 240 mg (treatment B)
EXPERIMENTALDFN-15 240 mg (treatment B)
Placebo (treatment C)
PLACEBO COMPARATORPlacebo (treatment C)
Interventions
DFN-15 Dose A administered
DFN-15 Dose B administered
Placebo administered
Eligibility Criteria
You may qualify if:
- Patients with a history of episodic migraine (as defined by International Classification of Headache Disorders \[ICHD\]-228) who experience an average of 2 to 6 migraine attacks a month for the past 12 months with no more than 14 headache days per month, and with at least 48 hours of headache-free time between migraine attacks;
- Patients with onset of migraine with or without aura before age 50;
- Patients who have migraine with or without aura, in which the aura cannot last longer than 60 minutes;
- Patients who report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale.
You may not qualify if:
- Patients with medication overuse headache (MOH) as defined by ICHD-228:
- Opioids ≥ 10 days a month during the 90 days prior to screening
- Combination medications (eg, Fiorinal® ≥ 10 days a month)
- Nonsteroidal anti-inflammatory drugs (NSAIDs) or other simple medications \> 14 days a month during the 90 days prior to screening
- Triptans or ergots ≥ 10 days a month during the 90 days prior to screening
- Patients on chronic warfarin sodium;
- Patients taking monoamine oxidase-A (MAO-A) inhibitors;
- Patients on unstable dosages of chronic medications during the 3 months prior to and through screening, or who are not willing or able to maintain a stable pre-study dose throughout study participation;
- Patients with more than 6 migraine attacks a month and/or more than 14 headache days a month (based upon patient self-report);
- Patients with hemiplegic migraine or migraine with brain stem aura or other forms of neurologically complicated migraine;
- Patients with atypical aura;
- Patients with prolonged aura (more than 1 hour).
- Patients with a history of stroke or transient ischemic attack;
- Patients with a history of migralepsy or a concurrent diagnosis of seizure disorder;
- Patients who cannot differentiate between a migraine headache and a tension-type or cluster headache or any other non-migraine headache;
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806, United States
California Medical Clinic for Headache
Santa Monica, California, 90404, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinvest/ A Division of Banyan Group, Inc.
Springfield, Missouri, 65807, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Related Publications (1)
Munjal S, Bennett A. Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study. Neuropsychiatr Dis Treat. 2017 Nov 7;13:2797-2802. doi: 10.2147/NDT.S151834. eCollection 2017.
PMID: 29158678RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2015
First Posted
June 15, 2015
Study Start
June 5, 2015
Primary Completion
December 1, 2015
Study Completion
May 5, 2016
Last Updated
May 22, 2018
Record last verified: 2018-04