Trial in Adult Subjects With Acute Migraines
Condition: Migraine, With or Without Aura
MeSH terms: Migraine Disorders
Intervention: Rimegepant; Placebo
Intervention description: 75 mg ODT QD; Placebo ODT to match rimegepant dose QD
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-blind to Sponsor, Investigator and Participant
Enrollment: 1811.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus
      placebo in subjects with Acute Migraines.
    

Eligibility criteria:

        Key Inclusion Criteria:

        1. Subject 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, Beta version [1] 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. Consistent migraine headaches of at least 2 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. Subjects 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. Subjects with contraindications for use of triptans may be included provided they meet
             all other study entry criteria.

        Key Exclusion Criteria:

          1. Subject with a history of HIV disease

          2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed
             cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and
             cerebral ischemia. subjects 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
             subjects can be included who have stable hypertension and/or diabetes for at least 3
             months prior to being enrolled)

          4. Subject has a current diagnosis of major depression, other pain syndromes, psychiatric
             conditions (e.g., schizophrenia), dementia, or significant neurological disorders
             (other than migraine) that, in the Investigator's opinion might interfere with study
             assessments.

          5. Subject has a history of gastric, or small intestinal surgery (including Gastric
             Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that
             causes malabsorption

          6. The subject has a history of current or evidence of any significant and/ or unstable
             medical conditions (e.g., history of congenital heart disease or arrhythmia, known
             suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion,
             would expose them to undue risk of a significant adverse event (AE) or interfere with
             assessments of safety or efficacy during the course of the trial.

          7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12
             months or subjects who have met DSM-V criteria for any significant substance use
             disorder within the past 12 months from the date of the screening visit.

          8. Subjects are excluded if they have previously participated in any BHV-30000
             (rimegepant) study within the last 2 years.

          9. Participation in any other investigational clinical trial while participating in this
             clinical trial