A Prospective, Open-Label Study Evaluating the Effectiveness of Rimegepant ODT or Zavegepant Nasal Spray for Acute Treatment of Migraine in the Emergency Department
University of South Florida
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 partic…