two dose levels of dfn-15 vs. placebo in patients with migraine headaches

Conditions: Migraine

Summary: crossover study of dfn-15 dose a versus dfn-15 dose b versus placebo in the treatment of migraine headaches.


Eligibility criteria:
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