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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02279082
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : August 28, 2017
Last Update Posted : March 9, 2018
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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

Condition or disease Intervention/treatment Phase
Acute Migraine Drug: DFN-02 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: DFN-02
DFN-02 to be taken during migraine attack
Drug: DFN-02
Active Experimental Drug

Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events [ Time Frame: 6 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02279082

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Sponsors and Collaborators
Dr. Reddy's Laboratories Limited

Publications of Results:
Other Publications:
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Responsible Party: Dr. Reddy's Laboratories Limited Identifier: NCT02279082    
Other Study ID Numbers: DFN-02-CD-010
First Posted: October 30, 2014    Key Record Dates
Results First Posted: August 28, 2017
Last Update Posted: March 9, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases