RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Rimegepant for Migraine

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.

Official registry: https://clinicaltrials.gov/study/NCT07667621 · University of South Florida · enrollment listed as 100

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Rimegepant, or Zavegepant. The registry lists allocation as randomized. Prospective, single-site, open-label, non-controlled pilot study consisting of two parallel trials.

They plan to enroll about 100 people at Tampa. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Rimegepant, Zavegepant

Primary outcome (registry wording): Pain relief at 2 hours without rescue medication

Who it is for (from inclusion criteria)

Ages 18 Years to any
At least 18 years of age
English and/or Spanish speaking patients

Who the registry excludes

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
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

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

1 listed

Tampa General Hospital Emergency Room — Tampa, Florida (recruiting)

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FAQ about this NCT record

Is NCT07667621 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07667621?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07667621?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary