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

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

Inclusion Criteria:

1. 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;
2. Patients with onset of migraine with or without aura before age 50;
3. Patients who have migraine with or without aura, in which the aura cannot last longer than 60 minutes;
4. Patients who report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale.

Exclusion Criteria:

1. 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

2. Patients on chronic warfarin sodium;

3. Patients taking monoamine oxidase-A (MAO-A) inhibitors;

4. 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;

5. Patients with more than 6 migraine attacks a month and/or more than 14 headache days a month (based upon patient self-report);

6. Patients with hemiplegic migraine or migraine with brain stem aura or other forms of neurologically complicated migraine;

7. Patients with atypical aura;

8. Patients with prolonged aura (more than 1 hour).

9. Patients with a history of stroke or transient ischemic attack;

10. Patients with a history of migralepsy or a concurrent diagnosis of seizure disorder;

11. Patients who cannot differentiate between a migraine headache and a tension-type or cluster headache or any other non-migraine headache;

12. Patients with a history of more than 10 tension-type headaches per month;

13. Patients with a history of cluster headache;

14. Patients with a diagnosis of ICHD-2 "probable migraine";

15. Patients with uncontrolled hypertension (screening blood pressure ≥ 140/90 mmHg despite appropriate pharmacotherapy);

16. Patients with severe renal impairment (defined as serum creatinine > 1.9 mg/dL);

17. Patients with serum total bilirubin > 1.9 mg/dL;

18. Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 3 times the upper limit of normal;

19. Patients with positive serology for human immunodeficiency virus (HIV), Hepatitis B surface antigen, Hepatitis C antibody.

20. Patients with a history of alcohol or substance abuse (including marijuana and medical marijuana) within 1 year that would compromise data collection;

21. 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;

22. 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);

23. 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