What side effects are associated with this type of intervention?

Common treatments for chronic sinusitis include nasal corticosteroids, which can cause side effects such as nasal irritation, nosebleeds, and, rarely, perforation of the nasal septum. Antihistamines may lead to drowsiness, dry mouth, and dizziness. Decongestants can cause insomnia, increased blood pressure, and palpitations. Saline nasal irrigation is generally safe but can occasionally cause nasal irritation. Antibiotics, when used, may result in gastrointestinal upset, allergic reactions, and antibiotic resistance. Surgical options, while effective, carry risks of bleeding, infection, and complications related to anesthesia. For treatments similar to Rimegepant, such as triptans (e.g., sumatriptan, zolmitriptan), common side effects include taste disturbances, nasal irritation, and, less frequently, more serious cardiovascular events.

What prior FDA approvals exist?

There is limited information on FDA-approved treatments for chronic sinusitis that are similar to Rimegepant, a CGRP receptor antagonist. Generally, treatments for chronic sinusitis include nasal corticosteroids, antihistamines, and antibiotics. For more targeted therapies, biologics like dupilumab have been approved for chronic rhinosinusitis with nasal polyps. These treatments focus on reducing inflammation and managing symptoms rather than targeting CGRP pathways.

What other types of research exist?

Promising novel alternatives to Rimegepant for chronic sinusitis patients include biologics such as Dupilumab, which targets IL-4 and IL-13 pathways, and Omalizumab, which targets IgE. Both have shown efficacy in reducing nasal polyps and improving sinus symptoms in clinical trials. Additionally, advancements in endoscopic sinus surgery and drug-eluting stents may offer new therapeutic options.

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Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist

Rimegepant for Chronic Sinusitis

Phase 2 & 3

Waitlist Available

Research Sponsored by Biohaven Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

In the last month, have you had at least two moderate or severe episodes of facial pain or pressure?

Be older than 18 years old

Must not have

Do you have a primary headache disorder?

Have you had nasal or facial surgery in the last 6 months?

Timeline

Screening 14 days

Treatment Varies

Follow Up 59 days

Summary

This trial is testing whether rimegepant can help people with chronic rhinosinusitis (CRS), including those with nasal polyps. The medication works by blocking a protein that causes inflammation and pain, potentially offering relief for those who don't respond to usual treatments.

Who is the study for?

This trial is for people who've had at least two moderate or severe facial pain episodes linked to chronic rhinosinusitis in the last month, without significant medical abnormalities. Participants must not start new CRS treatments during the study and agree to birth control methods. Those with fungal sinus infections, medication-induced rhinitis, primary headache disorders, or recent nasal/facial surgery can't join.

What is being tested?

The trial is testing rimegepant (a drug that dissolves on the tongue) against a placebo to see which one better treats sudden flare-ups of chronic rhinosinusitis, with or without nasal polyps. The goal is to determine if rimegepant can safely reduce symptoms like facial pain.

What are the potential side effects?

Possible side effects of rimegepant include nausea, dizziness, dry mouth and sleepiness. Since it's being compared with a placebo (a treatment with no active drug), some participants may experience no side effects related to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 14 days3 visits

Treatment ~ Varies

Follow Up ~ 59 days0 visits

Screening ~ 14 days

Treatment ~ Varies

Follow Up ~59 days

This trial's timeline: 14 days for screening, Varies for treatment, and 59 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of chronic rhinosinusitis with or without nasal polyps

Secondary study objectives

To evaluate rimegepant compared to placebo on change from baseline in nasal discharge

To evaluate rimegepant compared to placebo on change from baseline in nasal obstruction (congestion)

To evaluate rimegepant compared to placebo on change from baseline of Total Nasal Symptom Score (TNSS)

+2 more

Trial Design

2Treatment groups

Active Control

Group I: rimegepant 75 mg ODTActive Control1 Intervention

One dose of rimegepant 75 mg ODT

Group II: Matching PlaceboActive Control1 Intervention

One dose of matching placebo

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Sinusitis aim to promote sinus drainage, reduce chronic inflammation, and eradicate infecting pathogens. Topical therapies, such as nasal corticosteroids, reduce inflammation directly in the sinus mucosa, while saline irrigations help clear mucus and allergens. Antibiotics are used to treat bacterial infections. Rimegepant, a CGRP receptor antagonist, is being studied for its potential to reduce inflammation and pain by blocking the calcitonin gene-related peptide (CGRP) pathway, which is involved in inflammatory processes. This is particularly relevant for Chronic Sinusitis patients as it offers a novel approach to managing inflammation and associated symptoms, potentially improving their quality of life.

Developing a core outcome set for chronic rhinosinusitis: a systematic review of outcomes utilised in the current literature.Topical therapies in the management of chronic rhinosinusitis: an evidence-based review with recommendations.