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Recruiting Phase 4 NCT06401642

Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications

Trial Parameters

Condition Migraine
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-03-22
Completion 2027-03
Interventions
Zavegepant

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria * 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. * Atogepant * Eptinezumab * Erenumab * Fremanezumab * Galcanezumab * Rimegepant Exclusion Criteria * 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 Eligibility Notes * Participants may have either episodic or chronic migraine. * Prior use of zavegepant and other gepants is permitted. * Participants can be using migraine preventive medications/treatments

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