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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Rimegepant 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 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
Tampa General Hospital Emergency Room
Tampa, Florida, United States
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
Time frame: 2 hours post-study drug administration
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.
Time frame: 2 hours post-study drug administration
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
Time frame: 60 minutes post-study drug administration
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