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Completed

NCT Number: NCT05248997

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

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.

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Key information

Conditions

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San Diego Clinical Research Center, La Mesa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rimegepant 75 mg ODT

Drug

One dose of rimegepant 75 mg ODT

Matching Placebo

Drug

One dose of matching placebo

Primary outcomes

  1. Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose

    Time frame: Baseline, 2 hours post-dose

    Facial pain/pressure/fullness was assessed using an NRS score ranging in integers from 0 to 10, with 0 being "no facial pain/pressure/fullness" and 10 being "worst imaginable facial pain/pressure/fullness." Higher scores signified worse condition.

Secondary outcomes

  1. Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose

    Time frame: Baseline, 2 hours post-dose

    TNSS was calculated as the sum of 3 symptom scores: facial pain/pressure/fullness, score ranged from 0 (no facial pain/pressure/fullness) to 10 (worst imaginable facial pain/pressure/fullness); nasal obstruction (congestion), score ranged from 0 (no nasal obstruction (congestion) to 10 (worst imaginable nasal obstruction (congestion); and nasal discharge, score ranged from 0 (no nasal discharge) to 10 (worst nasal discharge). TNSS overall score ranged from 0 (no nasal symptom) to 30 (worst nasal symptom); higher scores signified worse condition.

  2. Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose

    Time frame: Baseline, 2 hours post-dose

    Nasal obstruction (congestion) severity was assessed using a NRS ranging in integers from 0 (no nasal obstruction [congestion]) to 10 (worst imaginable nasal obstruction [congestion]). Higher scores signified worse condition.

  3. Change From Baseline in Nasal Discharge at 2 Hours Post-Dose

    Time frame: Baseline, 2 hours post-dose

    Nasal discharge severity was assessed using a NRS ranging in integers from 0 (no nasal discharge) to 10 (worst imaginable nasal discharge). Higher scores signified worse condition.

  4. Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose

    Time frame: 2 hours post-dose

    Headache pain relief was defined as a headache pain level of none or mild at 2 hours post-dose on a 4-point Likert scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe).

  5. Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose

    Time frame: Through 24 hours post-dose

    Post 2 hours after dosing with study medication and after the 2-hour assessments were completed on the e-diary, participants were permitted to use the following rescue medications (non-study medications) such as: acetaminophen or aspirin, ibuprofen, naproxen (or any other type of nonsteroidal anti-inflammatory drug [NSAID]), oral antihistamines (non- sedating), oral decongestants, topical nasal decongestants, topical nasal anticholinergics.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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