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

Part of paid clinical trials in La Mesa, California.

Sponsor
Pfizer
Study ID
NCT05248997
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rimegepant 75 mg ODT — DRUG
    One dose of rimegepant 75 mg ODT
  • Matching placebo — DRUG
    One dose of matching placebo

Study Details

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 Dates

Start date
Feb 17, 2022
Status verified
Mar 2025
Primary completion
Mar 11, 2024
Completion
Apr 2, 2024

Study Design

Enrollment
261 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: rimegepant 75 mg ODT
    One dose of rimegepant 75 mg ODT
  • Active Comparator: Matching Placebo
    One dose of matching placebo

Primary Outcome Measure

Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose [ Time Frame: Baseline, 2 hours post-dose ]

Locations (33)

FacilityCityStateZIPSite coordinators
San Diego Clinical Research CenterLa MesaCalifornia91942-
Velocity Clinical San DiegoLa MesaCalifornia91942-
National Research InstitutePanorama CityCalifornia91402-
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.RosevilleCalifornia95628-
Sharp & Children's MRI Center, LLC (CT scan)San DiegoCalifornia92123-
Breathe Clear InstituteTorranceCalifornia90503-
Colorado ENT & AllergyColorado SpringsColorado80923-
Velocity Clinical Research, New Smyrna BeachEdgewaterFlorida32132-
The Medici Medical Research, LLCHollywoodFlorida33021-
Avantis Clinical ResearchMiamiFlorida33155-
Clinovation ResearchPompano BeachFlorida33064-
Treasure Valley Medical ResearchBoiseIdaho83706-
ChicagoENTChicagoIllinois60657-
Kentuckiana Ear, Nose & ThroatLouisvilleKentucky40205-
Best Clinical Trials, LLC (Administrative Only)New OrleansLouisiana70115-
George Stanley Walker, MDNew OrleansLouisiana70115-
University of Missouri Healthcare - Investigational PharmacyColumbiaMissouri65212-
University of Missouri Hospital (Radiology)ColumbiaMissouri65212-
University of Missouri Hospital & Clinics, ENT & Allergy Center of MissouriColumbiaMissouri65201-
Clinvest Research, LLCSpringfieldMissouri65810-
St Charles Clinical ResearchWeldon SpringMissouri63304-
Northwell Health Department of OtolaryngologyNew Hyde ParkNew York11042-
Tekton Research, Inc.EdmondOklahoma73013-
Allergy, Asthma & Clinical Research CenterOklahoma CityOklahoma73120-
Vital Prospects Clinical Research Institute, P.C.TulsaOklahoma74136-
Velocity Clinical Research, Grants PassGrants PassOregon97527-
Velocity Clinical Research, MedfordMedfordOregon97504-
Velocity Clinical Research, AndersonAndersonSouth Carolina29621-
Carolina ENT Clinic/CENTRI Inc.OrangeburgSouth Carolina29118-
Principle Research SolutionsSpokaneWashington99204-
Spokane Ear, Nose & Throat / Columbia Surgical SpecialistsSpokaneWashington99216-
Spokane Ear, Nose & Throat/ Columbia Surgical SpecialistsSpokaneWashington99201-
Allergy, Asthma & Sinus Center, S.C.GreenfieldWisconsin53228-

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San Diego Clinical Research Center· La Mesa, CAVelocity Clinical San Diego· La Mesa, CANational Research Institute· Panorama City, CASacramento Ear Nose and Throat Surgical and Medical Group, Inc.· Roseville, CASharp & Children's MRI Center, LLC (CT scan)· San Diego, CABreathe Clear Institute· Torrance, CA

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