Acute Migraine Treatment in the ED With Gepants

Conditions

• Migraine Headaches

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jun 5, 2025

Status verified

Jun 2025

Primary completion

Jan 6, 2026

Completion

Feb 4, 2026

Study Design

Enrollment

9 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rimegepant
  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.
• Experimental: Zavegepant
  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.

Primary Outcome Measure

Percentage of participants with pain relief at 2 hours without rescue medication [ Time Frame: 120 minutes (2 hours) ]

Locations (1)

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