Rimegepant for Chronic Sinusitis

Recruiting at 52 trial locations

Overseen By Pfizer Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Biohaven Pharmaceuticals, Inc.

Disqualifiers: Primary headache disorder, Nasal surgery, Rhinitis medicamentosa, Invasive fungal rhinosinusitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

286 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that you must agree to certain medication restrictions and not start new medications for chronic sinusitis during the study.

Is Rimegepant generally safe for humans?

Rimegepant, also known as Nurtec ODT, Vydura, BHV-3000, and BMS-927711, has been studied for safety in humans for conditions like migraines. It is generally considered safe, with common side effects including nausea and dry mouth, but serious side effects are rare. Always consult with a healthcare provider for personalized advice. ^{1 2 3 4 5}

How does the drug Rimegepant differ from other treatments for chronic sinusitis?

Rimegepant is unique because it is primarily known for treating migraines by blocking a protein called CGRP (calcitonin gene-related peptide), which is different from typical sinusitis treatments that often involve nasal sprays or decongestants. This novel approach could offer a new mechanism of action for managing chronic sinusitis symptoms. ^{6 7 8 9 10}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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.

Inclusion Criteria

You have no clinically significant abnormality identified on the medical or laboratory evaluation.

You agree to follow the rules of the study about which medications you can and cannot take, and you will not take any new medication to treat CRS symptoms during the study.

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

Exclusion Criteria

Do you have a primary headache disorder?

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

Do you have invasive fungal rhinosinusitis?

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of rimegepant 75 mg ODT or matching placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 hours

1 visit (virtual)

Treatment Details

Interventions

• Matching Placebo
• Rimegepant

Trial Overview 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.

Participant Groups

Group I: rimegepant 75 mg ODT Active Control 1 Intervention

One dose of rimegepant 75 mg ODT

Group II: Matching Placebo Active Control 1 Intervention

One dose of matching placebo

Rimegepant is already approved in United States, European Union, Canada, United Kingdom for the following indications:

Approved in United States as Nurtec ODT for:

• Acute treatment of migraine with or without aura in adults
• Preventative treatment of episodic migraine in adults

Approved in European Union as Vydura for:

• Prophylaxis and acute treatment of migraine in adults

Approved in Canada as Nurtec ODT for:

• Acute treatment of migraine with or without aura in adults
• Preventative treatment of episodic migraine in adults

Approved in United Kingdom as Vydura for:

• Prophylaxis and acute treatment of migraine in adults

Who Is Running the Clinical Trial?

Biohaven Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

30,100+

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Biohaven Pharmaceutical Holding Company Ltd.

Industry Sponsor

Trials

9

Recruited

6,300+

Findings from Research

In a double-blind, placebo-controlled trial involving 228 patients, the aqueous nasal formulation of ipratropium bromide significantly reduced the severity and duration of rhinorrhea in patients with perennial non-allergic rhinitis over an 8-week period.

The study found no serious or systemic anticholinergic side effects associated with ipratropium bromide, indicating it is a safe option for managing nasal symptoms compared to traditional fluorocarbon formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ipratropium bromide nasal spray in non-allergic rhinitis: efficacy, nasal cytological response and patient evaluation on quality of life. Georgitis, JW., Banov, C., Boggs, PB., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Adverse effects of benzalkonium chloride on the nasal mucosa: allergic rhinitis and rhinitis medicamentosa. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The new topical steroid ciclesonide is effective in the treatment of allergic rhinitis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Ipratropium bromide nasal spray in non-allergic rhinitis: efficacy, nasal cytological response and patient evaluation on quality of life. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Observational study investigating Ectoin® Rhinitis Nasal Spray as natural treatment option of acute rhinosinusitis compared to treatment with Xylometazoline. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Four-week use of oxymetazoline nasal spray (Nezeril) once daily at night induces rebound swelling and nasal hyperreactivity. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A new approach to the treatment of allergic nasopharyngitis. [2013]

8. Singapore pubmed.ncbi.nlm.nih.gov

A comparison of beclomethasone dipropionate aqueous nasal spray and sodium cromoglycate nasal spray in the management of seasonal allergic rhinitis. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of oxymetazoline nose drops on acute sinusitis in the rabbit. [2017]

10. Germany pubmed.ncbi.nlm.nih.gov

Tolerability and effects on quality of life of liposomal nasal spray treatment compared to nasal ointment containing dexpanthenol or isotonic NaCl spray in patients with rhinitis sicca. [2021]