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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

In brief

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.

Key facts

Study ID

NCT05248997

Run by

Pfizer

People needed

261

Starts

2022-02-17

Expected to finish

2024-04-02

Last updated by the study team

2025-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Allergy, Asthma & Sinus Center, S.C. — Greenfield, Wisconsin, United States
• 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
• Clinovation Research — Pompano Beach, Florida, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• ChicagoENT — Chicago, Illinois, United States
• Kentuckiana Ear, Nose & Throat — Louisville, Kentucky, United States
• Best Clinical Trials, LLC (Administrative Only) — New Orleans, Louisiana, United States
• George Stanley Walker, MD — New Orleans, Louisiana, United States
• University of Missouri Hospital & Clinics, ENT & Allergy Center of Missouri — Columbia, Missouri, United States
• University of Missouri Healthcare - Investigational Pharmacy — Columbia, Missouri, United States
• University of Missouri Hospital (Radiology) — Columbia, Missouri, United States
• Clinvest Research, LLC — Springfield, Missouri, United States
• St Charles Clinical Research — Weldon Spring, Missouri, United States
• Northwell Health Department of Otolaryngology — New Hyde Park, New York, United States
• Tekton Research, Inc. — Edmond, Oklahoma, United States
• Allergy, Asthma & Clinical Research Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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