Gepants for Acute Migraine in the Emergency Department

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-site, open-label pilot with two parallel arms, evaluating two gepants for acute migraine treatment in the emergency department. Participants receive either rimegepant or zavegepant during an ED visit and are followed for 28 days after discharge. There is no placebo or active comparator group. The trial aims to observe relief from symptoms in each parallel arm and collect post-discharge outcomes. Eligibility focuses on adults with migraine presenting to the ED, with language opportunities in English or Spanish.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • At least 18 years of age

  * Capacity to provide informed consent (without a Representative)
  * Emergency Department presentation for a headache consistent with migraine, based either on the treating clinical team's judgement, or fulfillment of International Classification of Headache Disorders (ICHD-3) criteria for migraine without aura or with typical aura, or for probable migraine without aura or with typical aura. It is acceptable if current headache duration is \>72 hours. Must have been headache free for \>48 hours prior to current attack.
  * Willing to participate in post-discharge telephone assessments
  * English and/or Spanish speaking patients

Exclusion Criteria:

* • Use of intranasal decongestants within 1 hour prior to study drug administration, due to the potential to decrease absorption of intranasal zavegepant.

  * Use of analgesics or abortive headache medications within 60 minutes of study medication administration
  * 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 ischemic cardiovascular disease, diabetes, or hypertension (diagnosed or likely based on multiple readings), that was recently diagnosed within 3 months of screening or is currently uncontrolled or unstable
  * History of any stroke within 3 months, or any lifetime stroke and age ≥65 years
  * History of significant peripheral vascular disease, as assessed by the investigator or qualified delegate
  * History of Raynaud's Phenomenon (medically diagnosed, or non-medically diagnosed with affirmative responses to both unusual sensitivity and finger color change with cold exposure)
  * History of severe hepatic impairment, as assessed by the investigator or qualified delegate
  * History of kidney disease stage 4 (eGFR \<30 mL/min/1.73 m2)
  * 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

    * All individuals of childbearing potential must have a negative pregnancy test at screening (urine or serum).
    * A person is considered to be of childbearing potential if possessing female reproductive organs at birth, post-menarchal, has not reached a post-menopausal state (≥12 continuous months of amenorrhea with no cause identified other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).

Where it's running

• Tampa General Hospital Emergency Room
  Tampa, Florida, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.