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

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