An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)
Condition: Migraine Headaches
MeSH terms: Migraine Disorders; Headache
Intervention: Sumatriptan 10 mg Nasal Spray; Sumatriptan Placebo Nasal Spray
Intervention description: 100 μL nasal spray once; 100 μL nasal spray once
Intervention MeSH terms: Sumatriptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Aura

Summary:

      A safety and efficacy study of DFN-02 (Sumatriptan Nasal Spray 10 mg), being conducted at
      multiple centers in the United States.
    

Eligibility criteria:

        Inclusion Criteria:

          1. A history of episodic migraine who experience an average of 2 to 8 migraine attacks
             per month for at least the past 12 months, with no more than 14 headache days per
             month, and with 48 hours of headache free time between migraine headaches

          2. Patients who have migraine with or without aura. If migraine with aura, the aura
             cannot last longer than 60 minutes.

          3. Patients who are willing and able to:

               1. Evaluate and record pain, migraine symptoms, and study medication effectiveness
                  information in real-time using a diary for the duration of the study;

               2. Record each instance of the use of study medication and rescue medication in a
                  patient diary in real-time for the duration of the study;

               3. Comply with all other study procedures and scheduling requirements.

        Exclusion Criteria:

          1. Minors, even if they are in the specified study age range

          2. Medication overuse:

               1. Opioids ≥ 10 days during the 90 days prior to screening

               2. Combination medications (e.g., Fiorinal®) ≥ 10 days during the 90 days prior to
                  screening (only applies if combination medication contains an opioid and/or
                  barbiturate)

               3. Nonsteroidal Anti-inflammatory Drugs or other simple medications ˃ 14 days a
                  month during the 90 days prior to screening

               4. Triptans or ergots ≥ 10 days a month during the 90 days prior to screening

          3. Treated with onabotulinumtoxinA (Botox®) or other botulinum toxin treatment within 4
             months prior to screening for migraine prophylaxis (patients who were treated with
             same for cosmetic purposes may be allowed on a case-by-case basis after approval from
             the Medical Monitor)

          4. A history of or current neurological or psychiatric impairment, or cognitive
             dysfunction that, in the opinion of the Investigator, would compromise data collection

          5. Use of antipsychotics at least 15 days prior to randomization

          6. Patients who received treatment with an investigational drug or device within 30 days
             prior to randomization, or within 3 months if associated with central nervous system

          7. Patients who participated in a central nervous system clinical trial within 3 months
             prior to randomization

          8. Patients who test positive for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HBsAg), or hepatitis C virus (HCV) antibody serology testing

          9. Patients who are employees or immediate relatives of the employees of the Sponsor, any
             of its affiliates or partners, or of the clinical study research site