Rimegepant + Zavegepant for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test two medications, rimegepant and zavegepant, for their effectiveness in treating migraines in the Emergency Department. Both medications have approval for migraines but are typically used outside the hospital. The study will explore whether these medications can provide quicker relief and reduce time spent in the emergency room compared to traditional treatments. Individuals who have experienced migraines for at least a year and are currently suffering from a severe headache might be suitable candidates for this study. As a Phase 4 trial, this research seeks to understand how these FDA-approved and effective treatments can benefit more patients.
Do I have to stop taking my current medications for the trial?
The trial requires you to stop using certain medications that could interact with the study drugs, such as specific strong or moderate inducers and inhibitors, within 7 days or 5 half-lives before participating. Additionally, you cannot use analgesics or headache medications within 2 hours of consent or intranasal decongestants within 12 hours.
What is the safety track record for these treatments?
Research has shown that both rimegepant and zavegepant are safe for treating migraines. Rimegepant, a 75 mg tablet that dissolves in the mouth, can be used safely once a day for extended periods. Studies indicate it is generally well-tolerated, with no major safety issues such as liver damage. In one study, about 55% of people using rimegepant experienced some side effects, but only 0.8% were serious.
Zavegepant, administered as a 10 mg nasal spray, has also been proven safe and effective for migraines. Reviews highlight its favorable safety profile compared to other treatments. Zavegepant is generally well-tolerated, even when used alongside other migraine prevention medicines.
Both treatments have received FDA approval for quick migraine relief, supporting their safety for this use.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about Rimegepant and Zavegepant for migraine treatment because they offer quick and convenient relief compared to traditional options. Rimegepant is a fast-acting oral disintegrating tablet that dissolves in the mouth, which is great for those who struggle with swallowing pills during a migraine. Zavegepant, on the other hand, is a nasal spray that provides rapid absorption, potentially offering faster relief than typical oral medications. Both treatments work by targeting the CGRP receptor, a novel approach compared to standard treatments like triptans, which constrict blood vessels. These unique delivery methods and mechanisms offer promising new options for managing acute migraines effectively.
What is the effectiveness track record for rimegepant and zavegepant as treatments for acute migraine in the Emergency Department?
This trial will compare the effectiveness of rimegepant and zavegepant for treating sudden migraine attacks. Participants will receive either a single dose of rimegepant 75 mg orally disintegrating tablet or a single dose of zavegepant 10 mg nasal spray during an Emergency Department encounter. Studies have shown that both rimegepant and zavegepant effectively treat sudden migraine attacks. Specifically, rimegepant has proven more effective than a placebo, reducing migraine symptoms better than a sugar pill, with high patient satisfaction and consistent results. Research indicates that zavegepant nasal spray provides significant pain relief and manages symptoms quickly and safely, similar to taking a pill. Both treatments are well-tolerated, causing few side effects. These medications have FDA approval for migraines, and their use in emergencies could offer faster relief than traditional IV methods.56789
Who Is on the Research Team?
Jonathan Schimmel
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
This trial is for adults in the Emergency Department who meet the criteria for migraine or probable migraine, with or without aura. Participants will be given either rimegepant orally or zavegepant as a nasal spray to treat acute migraines.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of rimegepant 75 mg ODT or zavegepant 10 mg nasal spray for acute migraine treatment during an Emergency Department encounter
Follow-up
Participants are monitored for pain relief at 60 minutes and 2 hours post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rimegepant
- Zavegepant
Trial Overview
The study tests if rimegepant (75 mg ODT) and zavegepant (10 mg nasal spray), both CGRP receptor antagonists, are effective for treating acute migraines in an ED setting. It's a pilot study with 100 patients divided equally between the two treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants in this arm will receive a single dose of zavegepant 10 mg nasal spray for acute migraine treatment during an Emergency Department (ED) encounter.
Participants in this arm will receive a single dose of rimegepant 75 mg orally disintegrating tablet (ODT) for acute migraine treatment during an Emergency Department (ED) encounter.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Pfizer
Industry Sponsor
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
Citations
Patient-reported outcomes of rimegepant for acute and ...
We compared TSQM scores at baseline and after treatment and found that both treatment cohorts showed improvements following rimegepant therapy.
2.
thejournalofheadacheandpain.biomedcentral.com
thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-024-01935-8Effectiveness and tolerability of rimegepant in the acute ...
Our data confirms rimegepant effectiveness and safety in the acute migraine treatment in a real-world setting in a cohort of participants.
3.
headachejournal.onlinelibrary.wiley.com
headachejournal.onlinelibrary.wiley.com/doi/full/10.1111/head.14995Efficacy and safety of rimegepant for the preventive treatment ...
Results showed that rimegepant was more effective than placebo in reducing monthly migraine days, with very few adverse effects.
Treatment Outcomes in People with Migraine Receiving ...
Patients prescribed rimegepant monotherapy reported high satisfaction, response consistency, and treatment optimization.
Rimegepant: A Review in the Acute Treatment and ...
Rimegepant was also significantly more effective than placebo irrespective of migraine attack frequency (≤ 4 or > 4 attacks per month) [32], ...
A multicenter, open-label long-term safety study of ...
Conclusions: Rimegepant 75 mg up to once per day as EOD + PRN for 12 weeks or PRN for up to 52 weeks was safe and well tolerated. No signal of hepatotoxicity, ...
7.
thejournalofheadacheandpain.biomedcentral.com
thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-024-01858-4Post-marketing safety concerns with rimegepant based on a ...
The US Food and Drug Administration (FDA) approved rimegepant for the acute treatment of adult migraine on February 27, 2020, and for the ...
Nurtec® ODT (rimegepant) | For Healthcare Professionals ^
Safety data. Safety profile studied up to 52 weeks for both acute and preventive migraine treatment. 1. View safety profile. Loading · View safety profile ...
212728Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov
The primary safety data comes from pooled data from the three pivotal studies. Analyses were conducted primarily on Group 1a and Group 3 ...
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