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Study of Gepants for Acute Migraine in the Emergency Department

This study is looking at how well two different medications, rimegepant and zavegepant, work to treat acute migraine headaches when given in the Emergency Department. You might be able to join if you are at least 18 years old and come to the Emergency Department with a migraine. The study wants to see if your pain is relieved within 2 hours of taking the medication, without needing other pain relief. This study is currently unclear on its recruitment status, but plans to enroll 100 people.

Study design
This is an open-label study, meaning you and your doctors will know which medication you receive. It's a pilot study with two separate groups, one receiving rimegepant and the other zavegepant.
What's involved
You would receive either rimegepant or zavegepant during your Emergency Department visit. There will be follow-up appointments for up to 28 days after you leave the hospital.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 28 days after leaving the Emergency Department.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07667621

A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
University of South Florida
~100 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:RimegepantZavegepant

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain relief at 2 hours without rescue medication
Measured over 2 hours post-study drug administration

Conditions

Migraine
Migraine Disease
Migraine in Adults
Migraine Headache
Acute Migraine
Migraine Without Aura
Migraine With Aura

Explore related trials

Migraine

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Stella Mensah, RN, BSN
[email protected]
813-844-7116
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

• 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

• 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).

What this trial measures

  • Pain relief at 2 hours without rescue medication2 hours post-study drug administration

    Evaluate the effectiveness of rimegepant 75 mg ODT or zavegepant 10 mg nasal spray as acute migraine treatments administered during ED encounters • Percentage of participants with pain relief of "mild" or "none" on a 4-point scale (none, mild, moderate, severe) at 2 hours post-study drug administration, without rescue medication