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

NCT ID
NCT06401642
Registry status
Recruiting
Study type
Interventional
Phase
Phase 4
Sponsor
Mayo Clinic
Conditions
Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 200 participants (Estimated).

What is being studied

  • Drug: Zavegepant

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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 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 Inclusion Criteria: • 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 Criteria • History of hypersensitivity reaction to rimegepant or to any of the components of rimegepant.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Arizona, United States: 1

Sample of listed locations

  • Mayo Clinic in Arizona — Phoenix, Arizona, 85254, United States — Recruiting

Study details

Start date
March 22, 2024
Primary completion date
March 1, 2027
Completion date
March 1, 2027
First posted
May 7, 2024

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06401642
Registry last updated
September 17, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT06401642 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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