Rimegepant + Zavegepant for Migraine

Overseen By Mitali Pradhan

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Analgesics, Intranasal decongestants, CGRP-targeting

Disqualifiers: Cardiovascular disease, Hypertension, Diabetes, Stroke, 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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

100 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{5 6 7 8 9}

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

Willingness to participate in post-discharge telephone or electronic follow-up assessments

I can make my own medical decisions.

I have been diagnosed with migraines.

Exclusion Criteria

My kidney function is severely reduced.

History of hypersensitivity reaction to rimegepant, zavegepant, or to any included inactive ingredients

I have a history of severe liver problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

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

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain relief at 60 minutes and 2 hours post-treatment

2 hours

1 visit (in-person)

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?

Group I: Zavegepant Experimental Treatment 1 Intervention

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.

Group II: Rimegepant Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Pfizer

Industry 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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12595842/

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/s10194-024-01935-8

Effectiveness 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.14995

Efficacy 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.

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000210468

Treatment Outcomes in People with Migraine Receiving ... Patients prescribed rimegepant monotherapy reported high satisfaction, response consistency, and treatment optimization.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10299922/

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], ...

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

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/s10194-024-01858-4

Post-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 ...

8. nurtec.pfizerpro.com nurtec.pfizerpro.com/

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 ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2020/212728Orig1s000MedR.pdf

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 ...