Safety and Efficacy Study in Adult Subjects With Acute Migraines
Condition: Migraine, With or Without Aura
MeSH terms: Migraine Disorders
Intervention: Rimegepant; Placebo
Intervention description: 75 mg tablet QD; Placebo tablet 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: 1485.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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

Eligibility criteria:

        Key Inclusion Criteria:

          1. Patient 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:

               -  Not more than 8 attacks of moderate or severe intensity per month within last 3
                  months

               -  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

          2. 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

          3. Patients 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 study entry.

          4. Patients with contraindications for use of triptans may be included provided they meet
             all other study entry criteria.

        Key Exclusion Criteria:

          1. Patient history of HIV disease

          2. Patient history with current evidence of uncontrolled, unstable or recently diagnosed
             cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and
             cerebral ischemia. Patients 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
             patients can be included who have stable hypertension and/or diabetes for 3 months
             prior to being enrolled)

          4. Patient has a current diagnosis of major depression, other pain syndromes, psychiatric
             conditions (eg, schizophrenia), dementia, or significant neurological disorders (other
             than migraine) that, in the Investigator's opinion, might interfere with study
             assessments

          5. Patient has a history of gastric, or small intestinal surgery, or has a disease that
             causes mal-absorption

          6. The patient has a history or current evidence of any significant and/or unstable
             medical conditions (eg, 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 patients who have met DSM-V criteria for any significant substance use
             disorder within the past 12 months from the date of the screening visit.