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.
Meets International Classification of Headache Disorders 3 (ICHD-3) diagnostic criteria for migraine with or without aura
At least 18 years of age
2- 8 migraine attacks per month
Participants should be on a calcitonin gene-related peptide (CGRP)-targeting preventive migraine medication on a stable dose for a) ≥2 months prior to zavegepant treatment if an oral gepant or a monoclonal antibody (mAb) injected monthly, or b) at least two treatments if a mAb injected each 3 months.
Primary headache disorders other than migraine (tension-type headache days are allowed)
History of hypersensitivity reaction to zavegepant or to any of the components of zavegepant
Participants may have either episodic or chronic migraine.
Prior use of zavegepant and other gepants is permitted.
Single group
Zavegepant
Drug10 mg intranasal
Headache relief in 2 hours
Percentage of participants who have meaningful headache relief within 2 hours of administering zavegepant
Headache relief in 4 hours
Percentage of participants who have meaningful headache relief within 4 hours of administering zavegepant
Functional disability level in 2 hours
Percentage of participants with functional disability level of normal or mildly impaired within 2 hours of administering zavegepant.
Functional disability level in 4 hours
Percentage of participants with functional disability level of normal or mildly impaired within 4 hours of administering zavegepant.
Adverse events
Percentage of participants and treated migraine attacks with treatment emergent adverse events
Serious adverse events
Percentage of participants and treated migraine attacks with serious treatment emergent adverse events
Discontinuation due to adverse events
Percentage of participants who discontinue zavegepant due to adverse events
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