NCT05248997

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Interventions

Type	Name	Description
DRUG	rimegepant 75 mg ODT	One dose of rimegepant 75 mg ODT
DRUG	Matching placebo	One dose of matching placebo

Timeline

• Start date: 2022-02-17
• Primary completion: 2024-03-11
• Completion: 2024-04-02
• First posted: 2022-02-21
• Last updated: 2025-03-26
• Results posted: 2025-03-26

Locations

33 sites across 1 country: United States

Regulatory

• FDA-regulated drug study