Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis
- Conditions
- Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
- Interventions
- Drug: rimegepant 75 mg ODTDrug: Matching placebo
- Registration Number
- NCT05248997
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
- 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.
- 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 33kg/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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rimegepant 75 mg ODT rimegepant 75 mg ODT One dose of rimegepant 75 mg ODT Matching Placebo Matching placebo One dose of matching placebo
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of chronic rhinosinusitis with or without nasal polyps 2 hours post-dose Mean change from baseline of facial pain/pressure/fullness on Numeric Rating Score (NRS) (0-10) score
- Secondary Outcome Measures
Name Time Method To evaluate rimegepant compared to placebo on change from baseline of Total Nasal Symptom Score (TNSS) 2 hours post-dose Total Nasal Symptom Score (TNSS) assessed using the number of evaluable subjects that report facial pain/pressure/fullness, nasal obstruction (congestion), and nasal discharge
To evaluate rimegepant compared to placebo on change from baseline in nasal obstruction (congestion) 2 hours post-dose Nasal obstruction (congestion) will be assessed using the number of evaluable subjects that report nasal obstruction (congestion) score on NRS (0-10)
To evaluate rimegepant compared to placebo on change from baseline in nasal discharge 2 hours post-dose Nasal discharge will be assessed using the number of evaluable subjects that report nasal discharge score on NRS (0-10)
To evaluate rimegepant compared to placebo on headache pain relief 2 hours post-dose Headache pain relief will be assessed using the number of evaluable subjects that report a headache pain level of moderate or severe intensity at baseline and then report a pain level of none or mild at 2 hours post-dose using a 4-point Likert scale
To evaluate rimegepant compared to placebo on the probability of requiring rescue medication Within 24 hours of initial treatment The probability of requiring rescue medication will be assessed using the number of subjects that take rescue medication within 24 hours after administration of study medication (rimegepant or placebo)
Trial Locations
- Locations (38)
ChicagoENT
🇺🇸Chicago, Illinois, United States
Advarra
🇺🇸Columbia, Maryland, United States
Velocity Clinical Research, Medford
🇺🇸Medford, Oregon, United States
Velocity Clinical San Diego
🇺🇸La Mesa, California, United States
National Research Institute
🇺🇸Panorama City, California, United States
Carolina ENT Clinic/CENTRI Inc.
🇺🇸Orangeburg, South Carolina, United States
WVU Medicine
🇺🇸Morgantown, West Virginia, United States
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
🇺🇸Roseville, California, United States
Velocity Clinical Research, Anderson
🇺🇸Anderson, South Carolina, United States
Principle Research Solutions
🇺🇸Spokane, Washington, United States
Velocity Clinical Research, Grants Pass
🇺🇸Grants Pass, Oregon, United States
Breathe Clear Institute
🇺🇸Torrance, California, United States
Allergy, Asthma & Sinus Center, S.C.
🇺🇸Greenfield, Wisconsin, United States
Spokane Ear, Nose & Throat / Columbia Surgical Specialists
🇺🇸Spokane, Washington, United States
San Diego Clinical Research Center
🇺🇸La Mesa, California, United States
Sharp & Children's MRI Center, LLC (CT scan)
🇺🇸San Diego, California, United States
Colorado ENT & Allergy
🇺🇸Colorado Springs, Colorado, United States
The Medici Medical Research, LLC
🇺🇸Hollywood, Florida, United States
Avantis Clinical Research
🇺🇸Miami, Florida, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Clinovation Research
🇺🇸Pompano Beach, Florida, United States
University of Missouri Healthcare - Investigational Pharmacy
🇺🇸Columbia, Missouri, United States
University of Missouri Hospital & Clinics, ENT & Allergy Center of Missouri
🇺🇸Columbia, Missouri, United States
University of Missouri Hospital (Radiology)
🇺🇸Columbia, Missouri, United States
Clinvest Research, LLC
🇺🇸Springfield, Missouri, United States
Northwell Health Department of Otolaryngology
🇺🇸New Hyde Park, New York, United States
Tekton Research, Inc.
🇺🇸Edmond, Oklahoma, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
Spokane Ear, Nose & Throat/ Columbia Surgical Specialists
🇺🇸Spokane, Washington, United States
Velocity Clinical Research, New Smyrna Beach
🇺🇸Edgewater, Florida, United States
University of Missouri Hospital - Clinical Research Center
🇺🇸Columbia, Missouri, United States
St Charles Clinical Research
🇺🇸Weldon Spring, Missouri, United States
Kentuckiana Ear, Nose & Throat
🇺🇸Louisville, Kentucky, United States
Allergy, Asthma & Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Best Clinical Trials, LLC (Administrative Only)
🇺🇸New Orleans, Louisiana, United States
Best Clinical Trials
🇺🇸New Orleans, Louisiana, United States
George Stanley Walker, MD
🇺🇸New Orleans, Louisiana, United States