A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.
Mayo Clinic
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.
Description
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 preventi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * Rimegepan…
Interventions
- DrugZavegepant
10 mg intranasal
Location
- Mayo Clinic in ArizonaPhoenix, Arizona