Clinical trial NCT02472418: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2015-06-15
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Pain Free, defined as a score of "0" on a numerical scale of "0" to "3"
timeFrame: 2 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
city: Springfield
country: United States
facility: Clinvest/ A Division of Banyan Group, Inc.
state: Missouri
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
Study officials:
References:
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.