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NCT07667621 · ClinicalTrials.gov registry record · Phase 1
A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department
A Phase 1 study, sponsored by University of South Florida.
- Not yet
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT07667621: Clinical Trial Phase 1 study, sponsored by University of South Florida.
NCT07667621 is a Phase 1 study that has not yet begun recruiting, run by University of South Florida. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07667621, a Phase 1 study, has not yet begun recruiting, sponsored by University of South Florida.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Rimegepant
- DRUG Zavegepant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-07 |
| Est. Completion | 2027-08 |
| Phase | Phase 1 |
What is known before NCT07667621 opens enrollment
NCT07667621 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 2 interventions - of which Rimegepant is the first listed.
NCT07667621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07667621 about?
NCT07667621 is a clinical study titled "A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants 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 allocate...
What is the current status of trial NCT07667621?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2026-07. Estimated completion is 2027-08.
What interventions are being tested in trial NCT07667621?
The interventions under investigation include: Rimegepant (DRUG), Zavegepant (DRUG).
Who is sponsoring clinical trial NCT07667621?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07667621's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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