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
2 other identifiers
interventional
261
1 country
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2022
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2022
CompletedStudy Start
First participant enrolled
February 17, 2022
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2024
CompletedResults Posted
Study results publicly available
March 26, 2025
CompletedMarch 26, 2025
March 1, 2025
2.1 years
January 31, 2022
March 5, 2025
March 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose
Facial pain/pressure/fullness was assessed using an NRS score ranging in integers from 0 to 10, with 0 being "no facial pain/pressure/fullness" and 10 being "worst imaginable facial pain/pressure/fullness." Higher scores signified worse condition.
Baseline, 2 hours post-dose
Secondary Outcomes (5)
Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose
Baseline, 2 hours post-dose
Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose
Baseline, 2 hours post-dose
Change From Baseline in Nasal Discharge at 2 Hours Post-Dose
Baseline, 2 hours post-dose
Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose
2 hours post-dose
Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose
Through 24 hours post-dose
Study Arms (2)
rimegepant 75 mg ODT
ACTIVE COMPARATOROne dose of rimegepant 75 mg ODT
Matching Placebo
ACTIVE COMPARATOROne dose of matching placebo
Interventions
Eligibility Criteria
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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (33)
San Diego Clinical Research Center
La Mesa, California, 91942, United States
Velocity Clinical San Diego
La Mesa, California, 91942, United States
National Research Institute
Panorama City, California, 91402, United States
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
Roseville, California, 95628, United States
Sharp & Children's MRI Center, LLC (CT scan)
San Diego, California, 92123, United States
Breathe Clear Institute
Torrance, California, 90503, United States
Colorado ENT & Allergy
Colorado Springs, Colorado, 80923, United States
Velocity Clinical Research, New Smyrna Beach
Edgewater, Florida, 32132, United States
The Medici Medical Research, LLC
Hollywood, Florida, 33021, United States
Avantis Clinical Research
Miami, Florida, 33155, United States
Clinovation Research
Pompano Beach, Florida, 33064, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
ChicagoENT
Chicago, Illinois, 60657, United States
Kentuckiana Ear, Nose & Throat
Louisville, Kentucky, 40205, United States
Best Clinical Trials, LLC (Administrative Only)
New Orleans, Louisiana, 70115, United States
George Stanley Walker, MD
New Orleans, Louisiana, 70115, United States
University of Missouri Hospital & Clinics, ENT & Allergy Center of Missouri
Columbia, Missouri, 65201, United States
University of Missouri Healthcare - Investigational Pharmacy
Columbia, Missouri, 65212, United States
University of Missouri Hospital (Radiology)
Columbia, Missouri, 65212, United States
Clinvest Research, LLC
Springfield, Missouri, 65810, United States
St Charles Clinical Research
Weldon Spring, Missouri, 63304, United States
Northwell Health Department of Otolaryngology
New Hyde Park, New York, 11042, United States
Tekton Research, Inc.
Edmond, Oklahoma, 73013, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136, United States
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, 97527, United States
Velocity Clinical Research, Medford
Medford, Oregon, 97504, United States
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621, United States
Carolina ENT Clinic/CENTRI Inc.
Orangeburg, South Carolina, 29118, United States
Spokane Ear, Nose & Throat/ Columbia Surgical Specialists
Spokane, Washington, 99201, United States
Principle Research Solutions
Spokane, Washington, 99204, United States
Spokane Ear, Nose & Throat / Columbia Surgical Specialists
Spokane, Washington, 99216, United States
Allergy, Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, 53228, United States
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2022
First Posted
February 21, 2022
Study Start
February 17, 2022
Primary Completion
March 11, 2024
Study Completion
April 2, 2024
Last Updated
March 26, 2025
Results First Posted
March 26, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.