RECRUITING

Acute Migraine Treatment in the ED With Gepants

Conditions

Migraine Headaches Migraine Emergency Department Gepants CGRP antagonists Rimegepant Zavegepant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-05

Study Completion:2026-10-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06985342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Mitali Pradhan

CONTACT

212-241-6500

mitali.pradhan@mountsinai.org

Principal Investigator

Jonathan Schimmel

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai Hospital

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

Jonathan Schimmel, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-05

Study Completion Date2026-10-30

Study Record Updates

Study Start Date2025-06-05

Study Completion Date2026-10-30

Terms related to this study

Keywords Provided by Researchers

Migraine
Emergency Department
Gepants
CGRP antagonists
Rimegepant
Zavegepant

Additional Relevant MeSH Terms

Migraine Headaches