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Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis | Clinical Trials | Clareo Health

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Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis

A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Chronic Rhinosinusitis (CRS) With or Without Nasal Polyps

NCT05248997•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy and safety of rimegepant versus placebo in the acute treatment of chronic rhinosinusitis (CRS) with and without nasal polyps.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 \> 35.0kg/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.
+2 more criteria

Locations (33)

San Diego Clinical Research Center

La Mesa, California, United States

Velocity Clinical San Diego

La Mesa, California, United States

National Research Institute

Panorama City, California, United States

Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.

Roseville, California, United States

Sharp & Children's MRI Center, LLC (CT scan)

San Diego, California, United States

Breathe Clear Institute

Torrance, California, United States

Colorado ENT & Allergy

Colorado Springs, Colorado, United States

Velocity Clinical Research, New Smyrna Beach

Edgewater, Florida, United States

The Medici Medical Research, LLC

Hollywood, Florida, United States

Avantis Clinical Research

Miami, Florida, United States

Key Dates

Start Date

February 17, 2022

Primary Completion Date

March 11, 2024

Completion Date

April 2, 2024

Last Updated

March 26, 2025

Enrollment

261

ACTUAL participants

Conditions

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Interventions

rimegepant 75 mg ODT

DRUG

Matching placebo

DRUG