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

NCT05248997

CompletedPhase 3

Sponsor: Pfizer

Conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Interventions: rimegepant 75 mg ODT, Matching placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (33)

La Mesa, California, United States
La Mesa, California, United States
Panorama City, California, United States
Roseville, California, United States
San Diego, California, United States
Torrance, California, United States
Colorado Springs, Colorado, United States
Edgewater, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Pompano Beach, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Columbia, Missouri, United States
Columbia, Missouri, United States
Columbia, Missouri, United States
Springfield, Missouri, United States
Weldon Spring, Missouri, United States
New Hyde Park, New York, United States
Edmond, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Grants Pass, Oregon, United States
Medford, Oregon, United States
Anderson, South Carolina, United States
Orangeburg, South Carolina, United States
Spokane, Washington, United States
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