Status:
RECRUITING
Acute Migraine Treatment in the ED With Gepants
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Pfizer
Conditions:
Migraine Headaches
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Depa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06985342
Start Date
June 5 2025
End Date
October 30 2026
Last Update
June 29 2025
Active Locations (1)
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1
Mount Sinai Hospital
New York, New York, United States, 10029