Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications
Recruiting
Phase 4Interventional Study
Migraine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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 migra…
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.
Contacts
No contact information available.
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