Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis
NCT ID: NCT05248997
Last Updated: 2025-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
261 participants
INTERVENTIONAL
2022-02-17
2024-04-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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rimegepant 75 mg ODT
One dose of rimegepant 75 mg ODT
rimegepant 75 mg ODT
One dose of rimegepant 75 mg ODT
Matching Placebo
One dose of matching placebo
Matching placebo
One dose of matching placebo
Interventions
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rimegepant 75 mg ODT
One dose of rimegepant 75 mg ODT
Matching placebo
One dose of matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, United States
Velocity Clinical Research, Medford
Medford, Oregon, United States
Velocity Clinical Research, Anderson
Anderson, South Carolina, United States
Carolina ENT Clinic/CENTRI Inc.
Orangeburg, South Carolina, United States
Spokane Ear, Nose & Throat/ Columbia Surgical Specialists
Spokane, Washington, United States
Principle Research Solutions
Spokane, Washington, United States
Spokane Ear, Nose & Throat / Columbia Surgical Specialists
Spokane, Washington, United States
Allergy, Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4951015
Identifier Type: OTHER
Identifier Source: secondary_id
BHV3000-316
Identifier Type: -
Identifier Source: org_study_id
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