Rimegepant for Chronic Sinusitis

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of rimegepant, a medication, compared to a placebo for treating chronic sinusitis, a condition that causes prolonged sinus inflammation and may include nasal polyps. Participants will receive either a single dose of rimegepant or a matching placebo to determine which is more effective and safe. Ideal candidates have experienced at least two episodes of moderate to severe facial pain or pressure in the past 30 days. The trial seeks to improve the quality of life for those dealing with chronic sinus issues. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to advancing medical care.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rimegepant is generally safe. In earlier studies, participants took 75 mg of rimegepant for up to a year and tolerated it well. No signs of liver damage appeared, which is important because some medicines can harm the liver. Participants also did not report any major side effects.

Rimegepant is already approved for treating migraines, indicating its safety since it has passed several safety checks for that use. Overall, the evidence suggests that rimegepant is generally safe for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic sinusitis?

Rimegepant is unique because it offers a new approach to treating chronic sinusitis using a calcitonin gene-related peptide (CGRP) receptor antagonist, a mechanism not typically used in existing treatments. Current standard care options for sinusitis often include nasal corticosteroids, antihistamines, and antibiotics, which primarily focus on reducing inflammation or treating infections. Unlike these, rimegepant targets the CGRP pathway, which is thought to play a role in pain and inflammation associated with sinus issues. Researchers are excited about rimegepant because it could provide faster relief and an alternative for patients who don't respond well to traditional treatments. Additionally, its oral disintegrating tablet form makes it easy for patients to take, potentially improving adherence and outcomes.

What evidence suggests that rimegepant might be an effective treatment for chronic rhinosinusitis?

This trial will compare rimegepant with a matching placebo for treating chronic rhinosinusitis (CRS). Research has shown that rimegepant may help treat CRS. In studies, people with CRS who took rimegepant experienced better results than those who took a placebo, regardless of nasal polyps. This suggests rimegepant can ease CRS symptoms. The treatment is generally safe and well-tolerated. Most side effects were mild, with common ones including mild upper respiratory infections. ^{1 2 5 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05248997

Safety and Efficacy of BHV-3000 (Rimegepant) Orally ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38659334/

A multicenter, open-label long-term safety study of ... The most common on-treatment adverse events (AEs) were upper respiratory tract infection (8.8%), nasopharyngitis (6.8%) and sinusitis (5.1%). Most AEs were mild ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/features/pipeline-moves-pfizer-prospects-rise-nurtec-completion/

Pipeline Moves: Pfizer's oral Nurtec approval prospects ... Pfizer's Nurtec orally disintegrating tablet (ODT) (rimegepant sulfate) saw a six-point increase in its Likelihood of Approval (LoA), settling ...

4. ctv.veeva.com ctv.veeva.com/study/safety-and-efficacy-of-bhv-3000-rimegepant-orally-disintegrating-tablet-for-the-acute-treatment-of

Safety and Efficacy of BHV-3000 (Rimegepant) Orally ... 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 ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/97/NCT05248997/SAP_001.pdf

Pfizer Inc. Protocol BHV3000-316 (C4951015) A Phase 2/3 ... Rimegepant will have efficacy superior to placebo in the acute treatment of CRS with or without polyps with a favorable safety profile. 1.2.

6. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.15002

A 52‐week open‐label extension study to evaluate the safety ... Conclusions. The OLE data showed favorable tolerability and sustained and increasing treatment benefits with rimegepant 75 mg (EOD and as-needed ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11127653/

Safety of Rimegepant in Patients Using Preventive ... Acute treatment of migraine with rimegepant 75 mg for up to 52 weeks was well tolerated and had a favorable safety profile in adults who were concomitantly ...