Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications
Recruiting now · Phase 4
Conditions studied: Migraine
In brief
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.
Key facts
- Study ID
- NCT06401642
- Run by
- Mayo Clinic
- People needed
- 200
- Starts
- 2024-03-22
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2025-09-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Mayo Clinic in Arizona — Phoenix, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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