drugset / Trial / NCT07667621
A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department
Phase 1
Not yet recruiting
100 enrolled
University of South Florida
Pfizer · collabTampa General Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-07
- Primary completion
- 2027-07
- Completion
- 2027-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rimegepant | Small molecule | 75 mg | Oral |
| Subject | Zavegepant | Small molecule | 10 mg | Intranasal |