Zavegepant (Zavzpret) is approved for the acute treatment of migraine with or without aura in the US. The purpose of this study is to investigate the effectiveness and tolerability of zavegepant for the acute treatment of migraine attacks amongst participants who are using calcitonin gene-related peptide (CGRP) migraine preventive treatments.
This is a phase IV, open-label, prospective, longitudinal clinical trial of intranasal zavegepant 10 mg, a CGRP receptor antagonist, for the acute treatment of migraine attacks amongst individuals who are concomitantly taking stable doses of CGRP targeting migraine preventive treatment (atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab, rimegepant). The effectiveness and tolerability of zavegepant will be assessed in this specific participant population. Participants who are not already taking a CGRP-targeting migraine preventive treatment but who meet criteria for migraine prevention according to their clinician's discretion, will have the option to start rimegepant 75 mg every other day (qod) for two months. After two months, continued eligibility for participation in the clinical trial of zavegepant will be assessed. Those receiving rimegepant for migraine prevention through their participation in this study will have the option to receive rimegepant for up to 32 consecutive weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
10 mg intranasal
Mayo Clinic in Arizona
Phoenix, Arizona, United States
RECRUITINGHeadache relief in 2 hours
Percentage of participants who have meaningful headache relief within 2 hours of administering zavegepant
Time frame: 2 hours
Headache relief in 4 hours
Percentage of participants who have meaningful headache relief within 4 hours of administering zavegepant
Time frame: 4 hours
Functional disability level in 2 hours
Percentage of participants with functional disability level of normal or mildly impaired within 2 hours of administering zavegepant.
Time frame: 2 hours
Functional disability level in 4 hours
Percentage of participants with functional disability level of normal or mildly impaired within 4 hours of administering zavegepant.
Time frame: 4 hours
Adverse events
Percentage of participants and treated migraine attacks with treatment emergent adverse events
Time frame: Approximately 24-32 weeks
Serious adverse events
Percentage of participants and treated migraine attacks with serious treatment emergent adverse events
Time frame: Approximately 24-32 weeks
Discontinuation due to adverse events
Percentage of participants who discontinue zavegepant due to adverse events
Time frame: Approximately 24-32 weeks
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