DFN-02 Open Label Safety Study in Patients With Acute Migraine
Condition: Acute Migraine
MeSH terms: Migraine Disorders
Intervention: DFN-02
Intervention description: Active Experimental Drug
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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

Eligibility 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)