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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472418
• Other study ID #: DFN-15-CD-002
• Status: Completed
• Phase: Phase 2
• Start date: June 5, 2015
• Est. completion date: May 5, 2016

Study information

• Verified date: April 2018
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 5, 2016
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders

Intervention

Drug:
• DFN-15 Dose A (treatment A)
DFN-15 Dose A administered
• DFN-15 Dose B (treatment B)
DFN-15 Dose B administered

Other:
• Placebo (treatment C)
Placebo administered

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Michigan Head Pain & Neurological Institute	Ann Arbor	Michigan
United States	Collaborative Neuroscience Network, LLC	Long Beach	California
United States	California Medical Clinic for Headache	Santa Monica	California
United States	Clinvest/ A Division of Banyan Group, Inc.	Springfield	Missouri
United States	MedVadis Research Corporation	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

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