NCT06985342

Acute Migraine Treatment in the ED With Gepants

A Prospective, Open-Label Study Examining the Use of Rimegepant ODT 75 mg or Zavegepant Nasal Spray 10 mg for Acute Treatment of Migraine in the Emergency Department Setting

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Migraine Headaches

Interventions

Type	Name	Description
DRUG	Rimegepant	Rimegepant 75 mg orally disintegrating tablet (ODT), administered as a single dose
DRUG	Zavegepant	Zavegepant 10 mg nasal spray, administered as a single dose

Timeline

• Start date: 2025-06-05
• Primary completion: 2026-10-30
• Completion: 2026-10-30
• First posted: 2025-05-22
• Last updated: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study