Back to resultsSafety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis
Primary Purpose
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rimegepant 75 mg ODT
Matching placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps focused on measuring Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) with Nasal Polyps, Chronic Rhinosinusitis (CRS) 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 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.
Sites / Locations
- San Diego Clinical Research CenterRecruiting
- Velocity Clinical San DiegoRecruiting
- National Research InstituteRecruiting
- Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.Recruiting
- Sharp & Children's MRI Center, LLC (CT scan)Recruiting
- Breathe Clear InstituteRecruiting
- Colorado ENT & Allergy
- Velocity Clinical Research, New Smyrna BeachRecruiting
- The Medici Medical Research, LLCRecruiting
- Avantis Clinical Research
- Clinovation ResearchRecruiting
- Clinovation ResearchRecruiting
- Treasure Valley Medical ResearchRecruiting
- ChicagoENT
- Kentuckiana Ear, Nose & ThroatRecruiting
- Best Clinical Trials, LLC (Administrative Only)Recruiting
- Best Clinical TrialsRecruiting
- George Stanley Walker, MDRecruiting
- Advarra
- University of Missouri Hospital & Clinics, ENT & Allergy Center of MissouriRecruiting
- University of Missouri Healthcare - Investigational PharmacyRecruiting
- University of Missouri Hospital (Radiology)Recruiting
- University of Missouri Hospital - Clinical Research CenterRecruiting
- Clinvest Research, LLC
- St Charles Clinical ResearchRecruiting
- Northwell Health Department of OtolaryngologyRecruiting
- Tekton Research, Inc.
- Allergy, Asthma & Clinical Research CenterRecruiting
- Vital Prospects Clinical Research Institute, P.C.Recruiting
- Velocity Clinical Research, Grants PassRecruiting
- Velocity Clinical Research, Medford
- Velocity Clinical Research, AndersonRecruiting
- Department of Otolaryngology-Head and Neck Surgery, Medical University of South CarolinaRecruiting
- Carolina ENT Clinic/CENTRI Inc.Recruiting
- Spokane Ear, Nose & Throat/ Columbia Surgical Specialists
- Principle Research Solutions
- Spokane Ear, Nose & Throat / Columbia Surgical Specialists
- WVU Medicine
- Allergy, Asthma & Sinus Center, S.C.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
rimegepant 75 mg ODT
Matching Placebo
Arm Description
One dose of rimegepant 75 mg ODT
One dose of matching placebo
Outcomes
Primary Outcome Measures
To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of chronic rhinosinusitis with or without nasal polyps
Mean change from baseline of facial pain/pressure/fullness on Numeric Rating Score (NRS) (0-10) score
Secondary Outcome Measures
To evaluate rimegepant compared to placebo on change from baseline of Total Nasal Symptom Score (TNSS)
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)
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
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
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05248997
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Keywords
Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) with Nasal Polyps, Chronic Rhinosinusitis (CRS) without Nasal Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
286 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rimegepant 75 mg ODT
Arm Type
Active Comparator
Arm Description
One dose of rimegepant 75 mg ODT
Arm Title
Matching Placebo
Arm Type
Active Comparator
Arm Description
One dose of matching placebo
Intervention Type
Drug
Intervention Name(s)
rimegepant 75 mg ODT
Intervention Description
One dose of rimegepant 75 mg ODT
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Intervention Description
One dose of matching placebo
Primary Outcome Measure Information:
Title
To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of chronic rhinosinusitis with or without nasal polyps
Description
Mean change from baseline of facial pain/pressure/fullness on Numeric Rating Score (NRS) (0-10) score
Time Frame
2 hours post-dose
Secondary Outcome Measure Information:
Title
To evaluate rimegepant compared to placebo on change from baseline of Total Nasal Symptom Score (TNSS)
Description
Total Nasal Symptom Score (TNSS) assessed using the number of evaluable subjects that report facial pain/pressure/fullness, nasal obstruction (congestion), and nasal discharge
Time Frame
2 hours post-dose
Title
To evaluate rimegepant compared to placebo on change from baseline in nasal obstruction (congestion)
Description
Nasal obstruction (congestion) will be assessed using the number of evaluable subjects that report nasal obstruction (congestion) score on NRS (0-10)
Time Frame
2 hours post-dose
Title
To evaluate rimegepant compared to placebo on change from baseline in nasal discharge
Description
Nasal discharge will be assessed using the number of evaluable subjects that report nasal discharge score on NRS (0-10)
Time Frame
2 hours post-dose
Title
To evaluate rimegepant compared to placebo on headache pain relief
Description
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
Time Frame
2 hours post-dose
Title
To evaluate rimegepant compared to placebo on the probability of requiring rescue medication
Description
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)
Time Frame
Within 24 hours of initial treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
San Diego Clinical Research Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical San Diego
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
National Research Institute
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Individual Site Status
Recruiting
Facility Name
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
City
Roseville
State/Province
California
ZIP/Postal Code
95628
Country
United States
Individual Site Status
Recruiting
Facility Name
Sharp & Children's MRI Center, LLC (CT scan)
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Breathe Clear Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado ENT & Allergy
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Individual Site Status
Terminated
Facility Name
Velocity Clinical Research, New Smyrna Beach
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Individual Site Status
Recruiting
Facility Name
The Medici Medical Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
Avantis Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinovation Research
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinovation Research
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33069
Country
United States
Individual Site Status
Recruiting
Facility Name
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Name
ChicagoENT
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Individual Site Status
Terminated
Facility Name
Kentuckiana Ear, Nose & Throat
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Individual Site Status
Recruiting
Facility Name
Best Clinical Trials, LLC (Administrative Only)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Name
Best Clinical Trials
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Name
George Stanley Walker, MD
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Name
Advarra
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Missouri Hospital & Clinics, ENT & Allergy Center of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Missouri Healthcare - Investigational Pharmacy
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Missouri Hospital (Radiology)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Missouri Hospital - Clinical Research Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinvest Research, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Individual Site Status
Terminated
Facility Name
St Charles Clinical Research
City
Weldon Spring
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwell Health Department of Otolaryngology
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Name
Tekton Research, Inc.
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Individual Site Status
Terminated
Facility Name
Allergy, Asthma & Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Name
Vital Prospects Clinical Research Institute, P.C.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Grants Pass
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Medford
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Individual Site Status
Terminated
Facility Name
Velocity Clinical Research, Anderson
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Recruiting
Facility Name
Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina ENT Clinic/CENTRI Inc.
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Individual Site Status
Recruiting
Facility Name
Spokane Ear, Nose & Throat/ Columbia Surgical Specialists
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
Individual Site Status
Terminated
Facility Name
Principle Research Solutions
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Terminated
Facility Name
Spokane Ear, Nose & Throat / Columbia Surgical Specialists
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Individual Site Status
Terminated
Facility Name
WVU Medicine
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Allergy, Asthma & Sinus Center, S.C.
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=BHV3000-316
Description
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Learn more about this trial
Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis
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