AzTrials
AzTrials

MigrainePhase 1NCT07667621

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

A Phase 1 study testing Rimegepant and Zavegepant in people with Migraine and Migraine Disease, run by University of South Florida at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Prospective, single-site, open-label, non-controlled pilot study consisting of two parallel trials. Participants will receive rimegepant or zavegepant for acute migraine treatment during a single Emergency Department visit, with post-discharge follow-up through 28 days. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Migraine, Migraine Disease, Migraine in Adults
What is being tested?
Rimegepant and Zavegepant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
15 Sep 2026to Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • • 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

Who cannot join

  • • 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
Show all 15Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Tampa General Hospital Emergency Room

    Tampa, Florida, 33606

    Hope Brunner, RN, BSN, 813-844-7289, hbrunner@tgh.org

    Ashley Bader, RN, BSN, abader@tgh.org

    Recruiting

Other trials in United States

About this study

Official title: A Prospective, Open-Label Study Evaluating the Effectiveness of Rimegepant ODT or Zavegepant Nasal Spray for Acute Treatment of Migraine in the Emergency Department

Prospective, single-site, open-label, non-controlled pilot study consisting of two parallel trials. Participants will receive rimegepant or zavegepant for acute migraine treatment during a single Emergency Department visit, with post-discharge follow-up through 28 days. Participants will be allocated to either the rimegepant trial or the zavegepant trial. The study design does not include a placebo or active comparator control group, and the two gepant study drugs are not designed to function as active comparator groups. The objective in this investigation is to examine relief from either rimegepant or zavegepant in separate parallel trials.

Being tested
Rimegepant, Zavegepant
Medical subject headings
Migraine Disorders, Migraine without Aura, Migraine with Aura

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RimegepantDrug

    Rimegepant 75 mg orally disintegrating tablet administered as a single dose during an Emergency Department visit for the acute treatment of migraine. The tablet is placed on or under the tongue and allowed to dissolve without water, consistent with FDA-approved labeling.

  • ZavegepantDrug

    Zavegepant 10 mg nasal spray administered as a single spray into one nostril during an Emergency Department visit for the acute treatment of migraine. Administration is consistent with FDA-approved labeling

Study groups in NCT07667621
Study groupRoleWhat they receive
Rimegepant (Parallel Trial)ExperimentalParticipants receive a single oral dose of rimegepant 75 mg orally disintegrating tablet during an Emergency Department visit for the acute treatment of migraine. This arm represents one of two independent, parallel pilot trials evaluating the effectiveness and safety of gepant medications in the Emergency Department. This arm is not intended for comparison with the zavegepant arm.
Receives: Drug: Rimegepant
Zavegepant (Parallel Trial)ExperimentalParticipants receive a single dose of zavegepant 10 mg administered as an intranasal spray during an Emergency Department visit for the acute treatment of migraine. This arm represents one of two independent, parallel pilot trials evaluating the effectiveness and safety of gepant medications in the Emergency Department. This arm is not intended for comparison with the rimegepant arm.
Receives: Drug: Zavegepant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain relief at 2 hours without rescue medication

    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

    Measured: 2 hours post-study drug administration

Secondary outcomes (2)

  1. Pain relief at 2 hours (with or without rescue medication)

    Evaluate the effectiveness of rimegepant 75 mg ODT or zavegepant 10 mg nasal spray as acute migraine treatments at 2 hours, with or without rescue medications

    • Percentage of participants with pain relief achieving "mild" or "none" on a 4-point scale at 2 hours post-study drug administration, analyzed in 2 groups: or 1) achieved pain relief with rimegepant or zavegepant plus rescue medication, or 2) did not achieve pain relief.

    Measured: 2 hours post-study drug administration

  2. Early pain relief at 60 minutes

    Evaluate the effectiveness of rimegepant 75 mg ODT or zavegepant 10 mg nasal spray as acute migraine treatments at a timepoint earlier than 2 hours

    • Percentage of participants with pain relief achieving "mild" or "none" on a 4-point scale at 60 minutes post-study drug administration

    Measured: 60 minutes post-study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2026
  2. Study start15 Sep 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07667621
Sponsor's protocol ID
STUDY009783
Status last verified
Sep 2026
First submitted
20 Jun 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rimegepant and Zavegepant in people with Migraine and Migraine Disease, run by University of South Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain relief at 2 hours without rescue medication (time frame: 2 hours post-study drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07667621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in