New migraine sprays and tablets tested in ER for quick relief
NCT ID NCT07667621
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will test two FDA-approved migraine drugs, rimegepant (a tablet that dissolves on the tongue) and zavegepant (a nasal spray), in 100 adults visiting the emergency department for a migraine. The goal is to see if these drugs provide pain relief within 2 hours without needing extra medication. It's an early, open-label pilot study, meaning everyone knows what they're getting, and there's no placebo group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rimegepant orally disintegrating tablet or zavegepant nasal spray
- What this could lead to
- If successful, this could show that these newer migraine drugs work well in an emergency setting, offering an alternative to standard ER treatments.
- What could go wrong
- This is a very early, small pilot study with no placebo group, so results are uncertain. It may not prove effectiveness or apply to all migraine patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tampa General Hospital Emergency Room
Tampa, Florida, 33606, United States
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