Santa Monica, California 90404

  • Migraine


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

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study Evaluating Efficacy of DFN-15 in Patients With Migraine Headache With or Without Aura

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:

65 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dr. Reddy's Laboratories Limited

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Study Dates

Start Date:June 5, 2015
Completion Date:May 5, 2016
Completion Type:Actual
Primary Completion Date:December 1, 2015
Primary Completion Type:Actual
Verification Date:April 2018
Last Changed Date:May 17, 2018
First Received Date:June 8, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Pain Free, defined as a score of "0" on a numerical scale of "0" to "3"
Time Frame:2 hour
Safety Issues:False
Description:Percentage of subjects who are migraine headache free at 2 hours after taking study drug administration

Study Interventions

Intervention Type:Drug
Name:DFN-15 Dose A (treatment A)
Description:DFN-15 Dose A administered
Arm Name:DFN-15 120 mg (treatment A)
Other Name:DFN-15 120 mg
Intervention Type:Drug
Name:DFN-15 Dose B (treatment B)
Description:DFN-15 Dose B administered
Arm Name:DFN-15 240 mg (treatment B)
Other Name:DFN-15 240 mg
Intervention Type:Other
Name:Placebo (treatment C)
Description:Placebo administered
Arm Name:Placebo (treatment C)
Other Name:Placebo (no active ingredient)

Study Arms

Study Arm Type:Experimental
Arm Name:DFN-15 120 mg (treatment A)
Description:DFN-15 120 mg (treatment A)
Study Arm Type:Experimental
Arm Name:DFN-15 240 mg (treatment B)
Description:DFN-15 240 mg (treatment B)
Study Arm Type:Placebo Comparator
Arm Name:Placebo (treatment C)
Description:Placebo (treatment C)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Dr. Reddy's Laboratories Limited

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Munjal S, Bennett A. Efficacy and safety of DFN-15, an oral liquid formulation of celecoxib, in adults with migraine: a multicenter, randomized, placebo-controlled, double-blind, crossover study. Neuropsychiatr Dis Treat. 2017 Nov 7;13:2797-2802. doi: 10.2147/NDT.S151834. eCollection 2017.

Data Source:

Date Processed: March 30, 2020

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