Acute Migraine Treatment in the ED With Gepants

NCT ID: NCT06985342

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-05
• Study Completion Date: 2026-10-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Rimegepant

Intervention Type: DRUG

Rimegepant 75 mg orally disintegrating tablet (ODT), administered as a single dose

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.

Group Type: EXPERIMENTAL

Zavegepant

Intervention Type: DRUG

Zavegepant 10 mg nasal spray, administered as a single dose

Interventions

Rimegepant

Rimegepant 75 mg orally disintegrating tablet (ODT), administered as a single dose

Intervention Type: DRUG

Zavegepant

Zavegepant 10 mg nasal spray, administered as a single dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Schimmel

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Schimmel

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Hospital

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mitali Pradhan

Role: CONTACT

mitali.pradhan@mountsinai.org

212-241-6500

Other Identifiers

STUDY-24-01677

Identifier Type: -

Identifier Source: org_study_id