A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rimegepant, Zavegepant.
- Who it may be relevant to
- Registry conditions: Migraine, Migraine Disease, Migraine in Adults, Migraine Headache. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug 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. - Drug 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 measures
- Pain relief at 2 hours without rescue medication [Time frame: 2 hours post-study drug administration]
Secondary outcome measures (2)
- Pain relief at 2 hours (with or without rescue medication) [Time frame: 2 hours post-study drug administration]
- Early pain relief at 60 minutes [Time frame: 60 minutes post-study drug administration]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Tampa General Hospital Emergency Room — Tampa
Identifiers
NCT: NCT07667621 · STUDY009783