RecruitingPhase 4NCT06401642

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

A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.

Sponsor

Mayo Clinic

Enrollment

200 participants

Start Date

Mar 22, 2024

Study Type

INTERVENTIONAL

Conditions

Migraine

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

Min Age: 18 Years

Inclusion Criteria11

Meets International Classification of Headache Disorders 3 (ICHD-3) diagnostic criteria for migraine with or without aura
At least 18 years of age
- 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
Must have 4 or more migraine days per month, on average, during the 2 months prior to the Screening Visit, according to participant self-report.

Exclusion Criteria8

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 in addition to the CGRP-targeting preventive treatment, as long as those treatments have been stable for at least two months at the time of enrollment.
Additional Eligibility Criteria for Participants to Start on Rimegepant for Migraine Prevention
History of hypersensitivity reaction to rimegepant or to any of the components of rimegepant.