Not yet recruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether rimegepant or zavegepant relieves a migraine during one emergency department visit in adults. Each person gets one of the drugs, with follow-up for 28 days after leaving the hospital. The drugs are studied separately, not compared with each other or with a placebo (a treatment with no active drug).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You can understand and agree to join the study on your own.
  • You visit the emergency department for a headache that the care team judges to be a migraine, or that meets set rules for migraine or likely migraine.
  • You had no headache for more than 48 hours before this attack. The current headache may have lasted more than 72 hours.
  • You agree to follow-up phone calls after leaving the hospital.
  • You speak English, Spanish, or both.

Who can't join

  • You used a nose spray for congestion within 1 hour before the study drug, or pain medicine or medicine to stop a headache within 60 minutes of the study drug.
  • You recently used certain medicines or foods that can affect how the study drugs work. The study team checks use within 7 days or longer, depending on how long the substance stays in your body.
  • You have heart or blood vessel disease caused by poor blood flow, diabetes, or high blood pressure that was diagnosed in the past 3 months or is not controlled or stable.
  • You had a stroke in the past 3 months, or you are 65 or older and have ever had a stroke.
  • You have serious blood flow problems in your arms or legs, or Raynaud’s—a condition involving unusual cold sensitivity and finger color changes in the cold.
  • You have severe liver problems or stage 4 kidney disease, meaning your kidneys filter blood very poorly.
  • You have had an allergic reaction to either study drug or its ingredients, or have ever used migraine drugs that target CGRP, a substance involved in migraine.
  • You are in police custody, pregnant, or breastfeeding. Anyone who could become pregnant must have a negative pregnancy test at screening.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (1)

FL