DFN-02 Open Label Safety Study in Patients With Acute Migraine

Acute Migraine Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279082
• Other study ID #: DFN-02-CD-010
• Status: Completed
• Phase: Phase 3
• First received: October 23, 2014
• Last updated: February 11, 2018
• Start date: September 2014
• Est. completion date: March 2016

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Migraine
• Migraine Disorders

Intervention

Drug:
• DFN-02
Active Experimental Drug

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Dent Neurologic Institute	Amherst	New York
United States	Michigan Head Pain & Neurological Institute	Ann Arbor	Michigan
United States	FutureSearch Trials of Neurology, LP	Austin	Texas
United States	Protenium Clinical Research, LLC	Bedford	Texas
United States	Florida Clinical Research Center	Bradenton	Florida
United States	Community Research	Cincinnati	Ohio
United States	Future Search Trials of Dallas, LP	Dallas	Texas
United States	Associated Neurologists of Southern CT, P.C.	Fairfield	Connecticut
United States	Collaborative Neuroscience Network, LLC	Long Beach	California
United States	Florida Clinical Research Center, LLC	Maitland	Florida
United States	Novex Clinical Research	New Bedford	Massachusetts
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Arizona Research Center	Phoenix	Arizona
United States	Northern California Clinical Research Center	Redding	California
United States	Breakthrough Clinical Trials	San Bernardino	California
United States	San Francisco Clinical Research Center	San Francisco	California
United States	California Medical Clinic for Headache	Santa Monica	California
United States	Carman Research	Smyrna	Georgia
United States	Clinvest/A Division of Banyan Group, Inc.	Springfield	Missouri
United States	Stanford University Medical Center	Stanford	California
United States	Neurology Clinical Research, Inc	Sunrise	Florida
United States	MedVadis Research Corporation	Watertown	Massachusetts
United States	Upstate Clinical Research Associates LLC	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 epi — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events		6 months