Two Dose Levels of DFN-15 vs. Placebo in Patients With Migraine Headaches

Study Overview
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Brief Summary
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Crossover study of DFN-15 dose A versus DFN-15 dose B versus Placebo in the treatment of migraine headaches.

Official Title
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A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study Evaluating Efficacy of DFN-15 in Patients With Migraine Headache With or Without Aura

Conditions
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Migraine

Intervention / Treatment
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* Drug: DFN-15 Dose A (treatment A)
* Drug: DFN-15 Dose B (treatment B)
* Other: Placebo (treatment C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; Patients with a history of more than 10 tension-type headaches per month; Patients with a history of cluster headache; Patients with a diagnosis of ICHD-2 probable migraine; Patients with uncontrolled hypertension (screening blood pressure ≥ 140/90 mmHg despite appropriate pharmacotherapy); Patients with severe renal impairment (defined as serum creatinine > 1.9 mg/dL); Patients with serum total bilirubin > 1.9 mg/dL; Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 3 times the upper limit of normal; Patients with positive serology for human immunodeficiency virus (HIV), Hepatitis B surface antigen, Hepatitis C antibody. Patients with a history of alcohol or substance abuse (including marijuana and medical marijuana) within 1 year that would compromise data collection; Patients with a history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the investigator, would compromise data collection; Patients with any other medical condition that, in the judgment of the investigator or medical monitor, would confound the objectives of the study (eg, cancer history [except basal cell carcinoma], systemic lupus erythematosus); Patients who have participated in a clinical trial involving any medication during the past 30 days or 5 half-lives of the study medication, whichever is longer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DFN-15 120 mg (treatment A)<br>DFN-15 120 mg (treatment A) | Drug: DFN-15 Dose A (treatment A)<br>* DFN-15 Dose A administered<br>* Other names: DFN-15 120 mg;|
| Experimental: DFN-15 240 mg (treatment B)<br>DFN-15 240 mg (treatment B) | Drug: DFN-15 Dose B (treatment B)<br>* DFN-15 Dose B administered<br>* Other names: DFN-15 240 mg;|
| Placebo Comparator: Placebo (treatment C)<br>Placebo (treatment C) | Other: Placebo (treatment C)<br>* Placebo administered<br>* Other names: Placebo (no active ingredient);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |