Your session is about to expire
← Back to Search
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
Awards & highlights
Study Summary
This trial will compare the effectiveness and safety of a new drug, rimegepant, to placebo in treating people with CRS, with or without nasal polyps.
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.Check my eligibility
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.See study design
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 belowExclusion 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of chronic rhinosinusitis with or without nasal polyps
Secondary outcome measures
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 moreTrial 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
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
36,849 Total Patients Enrolled
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,587 Total Patients Enrolled
1 Trials studying Chronic Sinusitis
129 Patients Enrolled for Chronic Sinusitis
Biohaven Pharmaceutical Holding Company Ltd.Industry Sponsor
8 Previous Clinical Trials
13,791 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.If you are a female participant, you must not be breastfeeding and agree to use birth control during the study.You have experienced moderate to severe facial pain or pressure at least twice in the past month.
Research Study Groups:
This trial has the following groups:- Group 1: rimegepant 75 mg ODT
- Group 2: Matching Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 14 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 7 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 59 Months after you stop receiving the treatment.
Chronic Sinusitis Patient Testimony for trial: Trial Name: NCT05248997 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any more open slots for this research project?
"Yes, this trial is still recruiting patients. The listing on clinicaltrials.gov says that the first posting was on February 17th, 2022 and the most recent update was on October 14th of the same year."
Answered by AI
Who else is applying?
What state do they live in?
New York
California
What site did they apply to?
Breathe Clear Institute
Velocity Clinical San Diego
Other
National Research Institute- Panorama City
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
3+
Why did patients apply to this trial?
Drugs and 4 surgeries. I have a lot of tension in my nose. I have suffered with this illness for year!
PatientReceived 1 prior treatment
help science find medicines to fight disease. Have ongoing rhinosinitus problems and symptoms.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How much does it pay? what does it involved to combat sinus infections?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Velocity Clinical San Diego: < 48 hours
- National Research Institute- Panorama City: < 48 hours
Average response time
- < 2 Days
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger