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

Trial Summary

What is the purpose of this trial?

This study evaluates the effectiveness of rimegepant 75 mg orally disintegrating tablet (ODT) single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments during Emergency Department (ED) encounters. Although these two calcitonin gene-related peptide receptors (CGRP) receptor antagonists are FDA-approved for the indication of acute migraine treatment, past studies have been limited to the outpatient setting. If these medications are effective in the Emergency Department, their delivery methods alone may have advantages over intravenous medications commonly used for acute migraine in EDs, including quicker time to treatment delivery, faster pain relief, and reduced ED length of stay. This investigation is a pilot study to examine rimegepant and zavegepant in an ED, to gain insight on effectiveness in this setting. This study will administer rimegepant 75 mg ODT single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments to 100 patients in the Emergency Department. It is a single center, open-label, non-controlled 2-group clinical trial (allocated 1:1 to rimegepant or zavegepant via pseudo-random assignment). The study will enroll adults in the ED meeting ICHD-3 criteria for migraine or probable migraine, with or without aura.

Research Team

Jonathan Schimmel

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

I have a history of severe liver problems.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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