Expired Study
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Watertown, Massachusetts 02472


Purpose:

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


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


NCT ID:

NCT02472418


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Watertown, Massachusetts 02472
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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