Randomized Trial in Adult Participants With Acute Migraines
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Zavegepant; Placebo
Intervention description: One dose of zavegepant; One dose of matching placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-blind to Sponsor, Investigator and Participant.
Enrollment: 1978.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Migraine; Phonophobia; Photophobia; Nausea

Summary:

      The purpose of this study is to test the safety and efficacy of BHV-3500 (zavegepant) versus
      placebo in the acute treatment of moderate or severe migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant has at least 1-year history of migraines (with or without aura),
             consistent with a diagnosis according to the International Classification of Headache
             Disorder, 3rd Edition, including the following:

               1. Migraine attacks present for more than 1 year with the age of onset prior to 50
                  years of age

               2. Migraine attacks, on average, lasting about 4-72 hours if untreated

               3. Not more than 8 attacks of moderate to severe intensity per month within the last
                  3 months

               4. At least 2 consistent migraine headache attacks of moderate or severe intensity
                  in each of the 3 months prior to the Screening Visit and maintains this
                  requirement during the Screening period

               5. Less than 15 days with headache (migraine or non-migraine) per month in each of
                  the 3 months prior to the Screening Visit and maintains this requirement during
                  the Screening Period.

               6. Participants on prophylactic migraine medication are permitted to remain on
                  therapy provided they have been on a stable dose for at least 3 months prior to
                  screening visit and the dose is not expected to change during the course of the
                  study.

               7. Participants with contraindications for use of triptans may be included provided
                  they meet all other study entry criteria.

          2. Male and Female participants ≥18 years of age.

        Exclusion Criteria:

          1. Participant with a history of HIV disease

          2. Participant history with current evidence of uncontrolled, unstable or recently
             diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery
             vasospasm, and cerebral ischemia. Participants with Myocardial Infarction (MI), Acute
             Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery,
             stroke or transient ischemic attack (TIA) during the 6 months prior to screening.

          3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however
             participants can be included who have stable hypertension and/or diabetes for at least
             3 months prior to being enrolled).

          4. Participants with major depressive episode within the last 12 months, major depressive
             disorder or any anxiety disorder requiring more than 1 medication for each disorder.

          5. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12
             months or participants who have met DSM-V criteria for any significant substance use
             disorder within the past 12 months.

          6. History of nasal surgery in the 6 months.

          7. Evidence at screening of significant nasal conditions that may affect the
             administration or absorption of the nasal product (e.g. severe septum deviation, nasal
             deformity or blockage, inflammation, perforation, mucosal erosion or ulceration,
             polyposis, nasal trauma)

          8. Participation in any other investigational clinical trial while participating in this
             clinical trial. Participation in a COVID-19 mRNA vaccine study (vaccine must be
             authorized under FDA emergency use authorization or approval) who are at least 30 days
             post last dose of the vaccine are permitted to be screened for this study.