This study evaluates the effectiveness of rimegepant 75 mg orally disintegrating tablet (ODT) single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments during Emergency Department (ED) encounters. Although these two calcitonin gene-related peptide receptors (CGRP) receptor antagonists are FDA-approved for the indication of acute migraine treatment, past studies have been limited to the outpatient setting. If these medications are effective in the Emergency Department, their delivery methods alone may have advantages over intravenous medications commonly used for acute migraine in EDs, including quicker time to treatment delivery, faster pain relief, and reduced ED length of stay. This investigation is a pilot study to examine rimegepant and zavegepant in an ED, to gain insight on effectiveness in this setting. This study will administer rimegepant 75 mg ODT single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments to 100 patients in the Emergency Department. It is a single center, open-label, non-controlled 2-group clinical trial (allocated 1:1 to rimegepant or zavegepant via pseudo-random assignment). The study will enroll adults in the ED meeting ICHD-3 criteria for migraine or probable migraine, with or without aura.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Rimegepant 75 mg orally disintegrating tablet (ODT), administered as a single dose
Zavegepant 10 mg nasal spray, administered as a single dose
Mount Sinai Hospital
New York, New York, United States
RECRUITINGPercentage of participants with pain relief at 2 hours without rescue medication
Percentage of participants reporting pain as 'mild' or 'none' at 2 hours post-study drug administration, without rescue medication. Pain is categorized as none, mild, moderate, or severe.
Time frame: 120 minutes (2 hours)
Percentage of participants with pain relief at 2 hours post treatment
Effectiveness of treatment measured as percentage of participants with pain relief achieving "mild" or "none" at 2 hours post-study drug administration. Pain is categorized as none, mild, moderate, or severe.
Time frame: 120 minutes (2 hours) post treatment
Percentage of participants with pain relief at 60 minutes post treatment
Effectiveness of treatment measured as percentage of participants with pain relief achieving "mild" or "none" at 60 minutes post-study drug administration. Pain is categorized as none, mild, moderate, or severe.
Time frame: 60 minutes post treatment
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