Summary:
Biohaven Pharmaceuticals is conducting a clinical trial to investigate the potential of rimegepant — a medicine currently FDA-approved for migraine in adults — to treat acute symptoms of CRS with or without nasal polyps.This study is to test a
medication (rimegepant) balready approved by the FDA for the treatment and prevention of migraine to learn how well it works and how safe it is for thesymptomatic treatment of CRS.Participation in this study allows you to take an active role in your healthcare and to help advance the development of medicines to potentially treat CRS.
To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of chronic rhinosinusitis with or without nasal polyps [ Time Frame: 2 hours post-dose ]
Mean change from baseline of facial pain/pressure/fullness on Numeric Rating Score (NRS) (0-10) score
Inclusion Criteria:
- At least two episodes of facial pain/pressure/fullness of moderate or severe intensity on a 4-point rating scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) in the past 30 days prior to the Screening Visit.
- Subject agrees to study-required medication restrictions and the restriction of not starting new medication to treat CRS symptoms during the course of the study.
- Subject agrees to study-required birth control methods during the course of the study, and female subjects must not be breastfeeding.
- No clinically significant abnormality identified on the medical or laboratory evaluation.
Exclusion Criteria:
- Subject has primary headache disorder.
- Subject has history of nasal or facial surgery within the 6 months prior to screening.
- Subject has ongoing rhinitis medicamentosa.
- Subject has diagnosed or suspected invasive fungal rhinosinusitis.
- Subject is currently receiving aspirin desensitization or maintenance therapy for Samter's Triad.
- Subject has a history of recurrent acute sinusitis (four or more episodes per year of acute bacterial rhinosinusitis (ABRS) without signs or symptoms of rhinosinusitis between episodes).
- Body Mass Index 33kg/m2.
- Subject history of exclusionary medical conditions such as HIV disease, cardiovascular conditions, uncontrolled hypertension or diabetes, psychiatric conditions, drug or alcohol abuse, malignancies, drug allergies, or any significant and/or unstable medical conditions.
- Subjects taking/using excluded therapies.
- Participation in clinical trial with non-biological investigational agents or investigational interventional treatments.
- Subjects who have previously participated in any BHV-3000/ BMS-927711/ rimegepant study.
- Planned participation in any other investigational clinical trial while participating in this clinical trial
Qualified Participants May Receive:
Health insurance is not required to participate in this study and the investigational drug, plus all study-related assessments and care will be provided at no cost to you.Compensation for time and travel will be provided for qualified patients.