Recruiting
Phase 1

Rimegepant & Zavegepant

Sponsor:

University of South Florida

Code:

NCT07667621

Conditions

Migraine

Migraine Disease

Migraine in Adults

Migraine Headache

Acute Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Rimegepant

Zavegepant

Study Details

Brief 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. 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.

Conditions

Migraine

Migraine Disease

Migraine in Adults

Migraine Headache

Acute Migraine

Study ID

NCT07667621

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rimegepant (Parallel Trial)

Participants 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.

experimental: Zavegepant (Parallel Trial)

Participants 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.

Interventions

Rimegepant

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.

Zavegepant

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

Primary outcome measure

  • Pain relief at 2 hours without rescue medication [ Time Frame: 2 hours post-study drug administration ]

Central Contacts and Locations

Locations

Tampa General Hospital Emergency Room

Recruiting

Tampa, Florida, United States, 33606

Contacts

Hope Brunner, RN, BSN

813-844-7289hbrunner@tgh.org

Ashley Bader, RN, BSN

abader@tgh.org

More Information

Sponsor

University of South Florida

Last update posted

Oct 27, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.