Acute Migraine Treatment in the ED With Gepants

Mount Sinai Health System

Status and phase: Not yet enrolling; Phase 4

Conditions: Migraine Headaches

Treatments: Drug: Rimegepant; Drug: Zavegepant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06985342

STUDY-24-01677

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Capacity to provide informed consent (without a Legally Authorized Representative)
• Prior migraine diagnosis (clinical or self-reported)
• Emergency Department presentation for a headache fulfilling International Classification of Headache Disorders (ICHD-3) criteria for migraine with typical aura or without aura, or criteria for probable migraine with typical aura or without aura. Duration of migraines should be ≥ 1 year. It is acceptable if current headache duration is >72 hours. Must have been headache free for >48 hours prior to current attack.
• Willingness to participate in post-discharge telephone or electronic follow-up assessments

Exclusion criteria

• Suspected secondary headache due to another cause, or primary headache disorder other than migraine or probable migraine
• Prior healthcare encounter for headache within 7 days
• Use of analgesics or abortive headache medications within 2 hours of consent
• Use of intranasal decongestant within 12 hours of consent
• Use of the following drug/food categories with potential for drug interactions within 7 days or 5 half-lives, whichever is longer: 1) CYP3A strong or moderate inducers, 2) CYP3A4 strong inhibitors, 3) P-glycoprotein (P-gp) inhibitors, 4) OATP1B3 transporter potent inhibitors/inducers, 5) NTCP transporter potent inhibitors/inducers
• History of cardiovascular disease, hypertension, or diabetes, recently diagnosed or currently uncontrolled or unstable
• History of stroke, peripheral vascular disease, or medically-diagnosed Raynaud's Phenomenon
• History of severe hepatic impairment, as assessed by the investigator or qualified delegate
• History of kidney disease stage 4 (creatinine clearance <30 mL/min or eGFR <35 mL/min/1.73 m2)
• History of nasal condition that may affect zavegepant administration, as assessed by the investigator or qualified delegate
• History of hypersensitivity reaction to rimegepant, zavegepant, or to any included inactive ingredients
• Lifetime use of CGRP-targeting acute or preventive migraine medications
• In custody of law enforcement
• Current pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Rimegepant

Experimental group

Description:

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.

Treatment:

Drug: Rimegepant

Zavegepant

Experimental group

Description:

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.

Treatment:

Drug: Zavegepant