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

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

Study Overview

• Status: Completed
• Conditions: Acute Migraine
• Intervention / Treatment: Drug: DFN-02

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
  • California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, LLC
    • Redding, California, United States, 96001
      • Northern California Clinical Research Center
    • San Bernardino, California, United States, 92408
      • Breakthrough Clinical Trials
    • San Francisco, California, United States, 94109
      • San Francisco Clinical Research Center
    • Santa Monica, California, United States, 90404
      • California Medical Clinic for Headache
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Southern CT, P.C.
  • Florida
    • Bradenton, Florida, United States, 34201
      • Florida Clinical Research Center
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center, LLC
    • Sunrise, Florida, United States, 33351
      • Neurology Clinical Research, Inc
  • Georgia
    • Smyrna, Georgia, United States, 30080
      • Carman Research
  • Massachusetts
    • New Bedford, Massachusetts, United States, 02740
      • Novex Clinical Research
    • 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.
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45255
      • Community Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology, LP
    • Bedford, Texas, United States, 76022
      • Protenium Clinical Research, LLC
    • Dallas, Texas, United States, 75231
      • Future Search Trials of Dallas, LP

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 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DFN-02; DFN-02 to be taken during migraine attack	Drug: DFN-02; Active Experimental Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment Emergent Adverse Events	6 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (Estimate): October 30, 2014

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: February 11, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: DFN-02-CD-010