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

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

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

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: DFN-15 Dose A (treatment A); Drug: DFN-15 Dose B (treatment B); Other: Placebo (treatment C)

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, LLC
    • Santa Monica, California, United States, 90404
      • California Medical Clinic for Headache
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • MedVadis Research Corporation
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain & Neurological Institute
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest/ A Division Of Banyan Group, Inc.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DFN-15 120 mg (treatment A)	Drug: DFN-15 Dose A (treatment A); DFN-15 Dose A administered; Other Names: DFN-15 120 mg
Experimental: DFN-15 240 mg (treatment B)	Drug: DFN-15 Dose B (treatment B); DFN-15 Dose B administered; Other Names: DFN-15 240 mg
Placebo Comparator: Placebo (treatment C)	Other: Placebo (treatment C); Placebo administered; Other Names: Placebo (no active ingredient)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): May 5, 2016

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: DFN-15-CD-002