Clinical trial NCT05248997: Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Keywords: Chronic Rhinosinusitis (CRS)
Chronic Rhinosinusitis (CRS) with Nasal Polyps
Chronic Rhinosinusitis (CRS) without Nasal Polyps
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose
timeFrame: Baseline, 2 hours post-dose
Secondary outcomes:
measure: Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose
timeFrame: Baseline, 2 hours post-dose
measure: Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose
timeFrame: Baseline, 2 hours post-dose
measure: Change From Baseline in Nasal Discharge at 2 Hours Post-Dose
timeFrame: Baseline, 2 hours post-dose
measure: Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose
timeFrame: Through 24 hours post-dose
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: San Diego Clinical Research Center
state: California
city: La Mesa
country: United States
facility: Velocity Clinical San Diego
state: California
city: Panorama City
country: United States
facility: National Research Institute
state: California
city: Roseville
country: United States
facility: Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Sharp & Children's MRI Center, LLC (CT scan)
state: California
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT & Allergy
state: Colorado
city: Edgewater
country: United States
facility: Velocity Clinical Research, New Smyrna Beach
state: Florida
city: Hollywood
country: United States
facility: The Medici Medical Research, LLC
state: Florida
city: Miami
country: United States
facility: Avantis Clinical Research
state: Florida
city: Pompano Beach
country: United States
facility: Clinovation Research
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Chicago
country: United States
facility: ChicagoENT
state: Illinois
city: Louisville
country: United States
facility: Kentuckiana Ear, Nose & Throat
state: Kentucky
city: New Orleans
country: United States
facility: Best Clinical Trials, LLC (Administrative Only)
state: Louisiana
city: New Orleans
country: United States
facility: George Stanley Walker, MD
state: Louisiana
city: Columbia
country: United States
facility: University of Missouri Hospital & Clinics, ENT & Allergy Center of Missouri
state: Missouri
city: Columbia
country: United States
facility: University of Missouri Healthcare - Investigational Pharmacy
state: Missouri
city: Columbia
country: United States
facility: University of Missouri Hospital (Radiology)
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research, LLC
state: Missouri
city: Weldon Spring
country: United States
facility: St Charles Clinical Research
state: Missouri
city: New Hyde Park
country: United States
facility: Northwell Health Department of Otolaryngology
state: New York
city: Edmond
country: United States
facility: Tekton Research, Inc.
state: Oklahoma
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Grants Pass
country: United States
facility: Velocity Clinical Research, Grants Pass
state: Oregon
city: Medford
country: United States
facility: Velocity Clinical Research, Medford
state: Oregon
city: Anderson
country: United States
facility: Velocity Clinical Research, Anderson
state: South Carolina
city: Orangeburg
country: United States
facility: Carolina ENT Clinic/CENTRI Inc.
state: South Carolina
city: Spokane
country: United States
facility: Spokane Ear, Nose & Throat/ Columbia Surgical Specialists
state: Washington
city: Spokane
country: United States
facility: Principle Research Solutions
state: Washington
city: Spokane
country: United States
facility: Spokane Ear, Nose & Throat / Columbia Surgical Specialists
state: Washington
city: Greenfield
country: United States
facility: Allergy, Asthma & Sinus Center, S.C.
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: