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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT02279082
First received: October 23, 2014
Last updated: February 7, 2017
Last verified: February 2017
  Purpose
A multi-center, open-label, safety study of DFN-02 for the Treatment of Acute Migraines

Condition Intervention Phase
Acute Migraine Drug: DFN-02 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Number of Treatment Emergent Adverse Events [ Time Frame: 6 months ]

Enrollment: 173
Study Start Date: September 2014
Study Completion Date: March 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DFN-02
Active DFN-02
Drug: DFN-02
Active Experimental Drug

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02279082

Locations
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Collaborative Neuroscience Network, LLC
Long Beach, California, United States, 90806
Northern California Clinical Research Center
Redding, California, United States, 96001
Breakthrough Clinical Trials
San Bernadino, California, United States, 92408
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
California Medical Clinic for Headache
Santa Monica, California, United States, 90404
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Connecticut
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, United States, 06824
United States, Florida
Florida Clinical Research Center
Bradenton, Florida, United States, 34201
Florida Clinical Research Center, LLC
Maitland, Florida, United States, 32751
Neurology Clinical Research, Inc
Sunrise, Florida, United States, 33351
United States, Georgia
Carman Research
Smyrna, Georgia, United States, 30080
United States, Massachusetts
Novex Clinical Research
New Bedford, Massachusetts, United States, 02740
MedVadis Research Corporation
Watertown, Massachusetts, United States, 02472
United States, Michigan
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Clinvest/A Division of Banyan Group, Inc.
Springfield, Missouri, United States, 65807
United States, New Mexico
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States, 87102
United States, New York
Dent Neurologic Institute
Amherst, New York, United States, 14226
Upstate Clinical Research Associates LLC
Williamsville, New York, United States, 14221
United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45255
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
FutureSearch Trials of Neurology, LP
Austin, Texas, United States, 78731
Protenium Clinical Research, LLC
Bedford, Texas, United States, 76022
Future Search Trials of Dallas, LP
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
  More Information

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02279082     History of Changes
Other Study ID Numbers: DFN-02-CD-010
Study First Received: October 23, 2014
Last Updated: February 7, 2017

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 23, 2017