Clinical trial NCT06985342: Acute Migraine Treatment in the ED With Gepants
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Migraine Headaches
Keywords: Migraine
Emergency Department
Gepants
CGRP antagonists
Rimegepant
Zavegepant
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2025-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of participants with pain relief at 2 hours without rescue medication
timeFrame: 120 minutes (2 hours)
Secondary outcomes:
measure: Percentage of participants with pain relief at 2 hours post treatment
timeFrame: 120 minutes (2 hours) post treatment
measure: Percentage of participants with pain relief at 60 minutes post treatment
timeFrame: 60 minutes post treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jonathan Schimmel
role: PRINCIPAL_INVESTIGATOR
References: