Clinical trial NCT02279082: DFN-02 Open Label Safety Study in Patients With Acute Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Migraine
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2014-10-30
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multi-center, open-label, safety study of DFN-02 for the Treatment of Acute Migraines


Eligibility criteria: Inclusion Criteria:

1. Patients with a history of acute migraine (using International Classification of Headache Disorders \[ICHD\] criteria, second edition);
2. Patients who, in the opinion of the investigator, are willing and able to:

   * Return to the study site within 72 hours of the first use of study medication,
   * Record each migraine and each instance of the use of study medication and rescue medication in a patient diary for the duration of the study;
3. Patients who can use the nasal spray device correctly after instruction.

Exclusion Criteria:

1. Patients on onabotulinumtoxinA (Botox®) or other botulinum toxin treatment; or history of receiving such treatment 180 days prior to screening;
2. Patients with a history of stroke or transient ischemic attack (TIA);
3. Patients with a history of migralepsy or a concurrent diagnosis of seizure disorder;
4. Patients who cannot differentiate between a migraine headache and a tension-type or cluster headache;
5. Patients with ischemic coronary artery disease (CAD; ie, angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetal's angina);
6. Patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders;
7. Patients with uncontrolled hypertension (screening systolic/diastolic blood pressure \> 140/90 mmHg);
8. Patients with peripheral vascular disease or ischemic bowel disease;
9. Patients taking any medications or with illnesses likely to affect the physiology of the nasal mucosa (ie, patients with nasal septum surgery, chronic sinusitis, or chronic nasal rhinitis). (Note: Patients who have acute conditions such as acute sinusitis may be rescreened 14 days after resolution of acute sinusitis.);
10. Patients with any abnormal nasal physiology or pathology which, in the opinion of the investigator, would not allow the objectives of the study to be accomplished;
11. Patients with known intolerance to nasal sprays;
12. Patients with severe renal impairment (defined as serum creatinine \> 2 mg/dL);
13. Patients with serum total bilirubin \> 2.0 mg/dL;
14. Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase \> 2.5 times the upper limit of normal (ULN);
15. Patients with a history of alcohol or substance abuse (including marijuana and medical marijuana) within 1 year that would compromise data collection;
16. Patients with a positive urine drug screen for illicit drugs or for prescription drugs not explained by stated concomitant medications. (Positive drug screen for marijuana is exclusionary.):

    1. Patients consuming opioids for the treatment of migraine or using opioids or barbiturates temporarily for a legitimate medical cause may participate as long as they do not meet the MOH criteria.
    2. Benzodiazepines are allowed if used for legitimate medical use.
    3. Chronic use of amphetamines to treat attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) and related disorders is allowed as long as the regimen has been stable for at least 3 months prior to screening and is expected to remain stable throughout the study.

    Note: For the above-mentioned conditions, the site must obtain medical monitor approval.
17. 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;
18. Patients who have received treatment with an investigational drug or device within 4 weeks of the screening visit or participated in a central nervous system clinical trial in the 3 months prior to screening;
19. Patients who test positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody serology testing.
20. 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)

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Redding
country: United States
facility: Northern California Clinical Research Center
state: California
city: San Bernardino
country: United States
facility: Breakthrough Clinical Trials
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Fairfield
country: United States
facility: Associated Neurologists of Southern CT, P.C.
state: Connecticut
city: Bradenton
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Sunrise
country: United States
facility: Neurology Clinical Research, Inc
state: Florida
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: New Bedford
country: United States
facility: Novex Clinical Research
state: Massachusetts
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
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates LLC
state: New York
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Trials of Neurology, LP
state: Texas
city: Bedford
country: United States
facility: Protenium Clinical Research, LLC
state: Texas
city: Dallas
country: United States
facility: Future Search Trials of Dallas, LP
state: Texas
Study officials:
References:
citation: Munjal S, Gautam A, Offman E, Brand-Schieber E, Allenby K, Fisher DM. A Randomized Trial Comparing the Pharmacokinetics, Safety, and Tolerability of DFN-02, an Intranasal Sumatriptan Spray Containing a Permeation Enhancer, With Intranasal and Subcutaneous Sumatriptan in Healthy Adults. Headache. 2016 Oct;56(9):1455-1465. doi: 10.1111/head.12905. Epub 2016 Sep 10.
citation: Munjal S, Brand-Schieber E, Allenby K, Spierings ELH, Cady RK, Rapoport AM. A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine. J Headache Pain. 2017 Dec;18(1):31. doi: 10.1186/s10194-017-0740-3. Epub 2017 Mar 1.