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

NCT02279082 | Completed Phase 3 Results

• 1 other identifier: DFN-02-CD-010
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Acute Migraine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events

  6 months

Study Arms (1)

DFN-02

EXPERIMENTAL

DFN-02 to be taken during migraine attack

Drug: DFN-02

Interventions

DFN-02 DRUG

Active Experimental Drug

DFN-02

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a history of acute migraine (using International Classification of Headache Disorders \[ICHD\] criteria, second edition);
• 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;
• Patients who can use the nasal spray device correctly after instruction.

You may not qualify if:

• Patients on onabotulinumtoxinA (Botox®) or other botulinum toxin treatment; or history of receiving such treatment 180 days prior to screening;
• Patients with a history of stroke or transient ischemic attack (TIA);
• Patients with a history of migralepsy or a concurrent diagnosis of seizure disorder;
• Patients who cannot differentiate between a migraine headache and a tension-type or cluster headache;
• 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);
• Patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders;
• Patients with uncontrolled hypertension (screening systolic/diastolic blood pressure \> 140/90 mmHg);
• Patients with peripheral vascular disease or ischemic bowel disease;
• 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.);
• 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;
• Patients with known intolerance to nasal sprays;
• Patients with severe renal impairment (defined as serum creatinine \> 2 mg/dL);
• Patients with serum total bilirubin \> 2.0 mg/dL;
• Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase \> 2.5 times the upper limit of normal (ULN);
• Patients with a history of alcohol or substance abuse (including marijuana and medical marijuana) within 1 year that would compromise data collection;

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (24)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Collaborative Neuroscience Network, LLC

Long Beach, California, 90806, United States

Location

Northern California Clinical Research Center

Redding, California, 96001, United States

Location

Breakthrough Clinical Trials

San Bernardino, California, 92408, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Associated Neurologists of Southern CT, P.C.

Fairfield, Connecticut, 06824, United States

Location

Florida Clinical Research Center

Bradenton, Florida, 34201, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Neurology Clinical Research, Inc

Sunrise, Florida, 33351, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Novex Clinical Research

New Bedford, Massachusetts, 02740, United States

Location

MedVadis Research Corporation

Watertown, Massachusetts, 02472, United States

Location

Michigan Head Pain & Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Clinvest/A Division of Banyan Group, Inc.

Springfield, Missouri, 65807, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Upstate Clinical Research Associates LLC

Williamsville, New York, 14221, United States

Location

Community Research

Cincinnati, Ohio, 45255, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

FutureSearch Trials of Neurology, LP

Austin, Texas, 78731, United States

Location

Protenium Clinical Research, LLC

Bedford, Texas, 76022, United States

Location

Future Search Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Related Publications (2)

• 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.

  PMID: 27613076 BACKGROUND

• 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.

  PMID: 28251391 RESULT

MeSH Terms

Interventions

DFN-02

Results Point of Contact

• Title: Clinical Operations Director
• Organization: Dr. Reddy's Laboratories

kgulbronson@promiuspharma.com

609-282-1476

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 30, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 9, 2018
• Results First Posted: August 28, 2017

Record last verified: 2018-02

Locations

US (24)