Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine
Condition: Acute Migraine
MeSH terms: Migraine Disorders
Intervention: Rimegepant; Placebo
Intervention description: One 75mg orally disintegrating tablet; Matching placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1648.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Migraine

Summary:

      This trial is to determine whether BHV3000 (rimegepant) 75mg is safe and effictive as a
      treatment for acute migraine in Chinese and Korean patients
    

Eligibility criteria:

        Inclusion Criteria:

        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 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 study of rimegepant
             or other experimental CGRP-antagonist study, or have been prescribed CGRP-antibodies
             within the last 6 months

          9. Participation in any other investigational clinical trial while participating in this
             clinical trial