Migraine
Conditions
Brief summary
Crossover study of DFN-15 dose A versus DFN-15 dose B versus Placebo in the treatment of migraine headaches.
Interventions
DRUGDFN-15 Dose A (treatment A)
DFN-15 Dose A administered
DRUGDFN-15 Dose B (treatment B)
DFN-15 Dose B administered
Placebo administered
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Free, defined as a score of 0 on a numerical scale of 0 to 3 | 2 hour | Percentage of subjects who are migraine headache free at 2 hours after taking study drug administration |
Countries
United States
Outcome results
None listed