Efficacy, Tolerability, and Safety Study of DFN-15
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: DFN-15 Active; DFN-15 Placebo
Intervention MeSH terms: Celecoxib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 622.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being
      conducted at multiple centers in the United States.
    

Eligibility criteria:

        Inclusion Criteria:

          1. A history of episodic migraine, who experience 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 attacks.

          2. Patients who have migraine with or without aura with onset before age 50 years

          3. Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity
             scale without treatment.

          4. Subjects who are willing and able to:

               1. Evaluate and record pain, migraine symptoms, and study drug effectiveness
                  information in real-time using a subject eDiary for the duration of the study;

               2. Record each instance of the use of study drug and rescue medication in real-time
                  using a subject eDiary 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 greater than or equal to 10 days during the 90 days prior to screening

               2. Combination medications (e.g., Fiorinal®) greater than or equal to 10 days during
                  the 90 days prior to screening (applies only if includes opioid and/or
                  barbiturate)

               3. Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14
                  days a month during the 90 days prior to screening

               4. Triptans or ergots greater than or equal to 10 days a month during the 90 days
                  prior to screening

          3. Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to
             screening. (If treated for cosmetic reasons, subjects may be included).

          4. Current treatment with antipsychotics or use of antipsychotics within 30 days prior to
             randomization.

          5. Patients who have received treatment with an investigational drug or device within 30
             days of randomization, or participated in a central nervous system clinical trial
             within 2 months prior to randomization

          6. Patients with positive screening test for human immunodeficiency virus [HIV], positive
             hepatitis B surface antigen (HBsAg), or positive hepatitis C virus [HCV] antibody

          7. Subjects who are employees or immediate relatives of the employees of the Sponsor, any
             of its affiliates or partners, or of the clinical research study site.