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.
• 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
• 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
Parallel
Rimegepant
DrugRimegepant 75 mg orally disintegrating tablet administered as a single dose during an Emergency Department visit for the acute treatment of migraine. The tablet is placed on or under the tongue and allowed to dissolve without water, consistent with FDA-approved labeling.
Zavegepant
DrugZavegepant 10 mg nasal spray administered as a single spray into one nostril during an Emergency Department visit for the acute treatment of migraine. Administration is consistent with FDA-approved labeling
Pain relief at 2 hours without rescue medication
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
Pain relief at 2 hours (with or without rescue medication)
Evaluate the effectiveness of rimegepant 75 mg ODT or zavegepant 10 mg nasal spray as acute migraine treatments at 2 hours, with or without rescue medications • Percentage of participants with pain relief achieving "mild" or "none" on a 4-point scale at 2 hours post-study drug administration, analyzed in 2 groups: or 1) achieved pain relief with rimegepant or zavegepant plus rescue medication, or 2) did not achieve pain relief.
Early pain relief at 60 minutes
Evaluate the effectiveness of rimegepant 75 mg ODT or zavegepant 10 mg nasal spray as acute migraine treatments at a timepoint earlier than 2 hours • Percentage of participants with pain relief achieving "mild" or "none" on a 4-point scale at 60 minutes post-study drug administration
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