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Zavegepant for Acute Migraine in Patients Using CGRP Preventives

This study is looking at how well and how safely zavegepant (10 mg intranasal) works to treat sudden migraine attacks. It's for people who are already using a CGRP-targeting medicine to prevent migraines. You might be able to join if you are at least 18 years old, have 2-8 migraine attacks per month, and meet the diagnostic criteria for migraine. The study wants to see if zavegepant helps relieve headache and improve your ability to function within 2 and 4 hours. The study is currently unclear on its recruitment status and plans to enroll 200 participants.

Study design
This is an open-label, prospective, longitudinal clinical trial (Phase 4) involving 200 participants. It is not blinded, meaning both you and the study team will know you are receiving zavegepant.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at 2 hours and 4 hours after treatment. If you are not already on a CGRP-targeting preventive and choose to start rimegepant through the study, you could receive it for up to 32 consecutive weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06401642

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
Mayo Clinic
~200 participants
Updated 2025-09-09 on ClinicalTrials.gov
What's tested:Zavegepant

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Headache relief in 2 hours
Measured over 2 hours
+3 more outcomes measured

Conditions

Migraine

Explore related trials

Migraine

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Todd Schwedt, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Michael R Leonard
[email protected]
480-342-2908
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
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.

What this trial measures

  • Headache relief in 2 hours2 hours

    Percentage of participants who have meaningful headache relief within 2 hours of administering zavegepant

  • Headache relief in 4 hours4 hours

    Percentage of participants who have meaningful headache relief within 4 hours of administering zavegepant

  • Functional disability level in 2 hours2 hours

    Percentage of participants with functional disability level of normal or mildly impaired within 2 hours of administering zavegepant.

  • Functional disability level in 4 hours4 hours

    Percentage of participants with functional disability level of normal or mildly impaired within 4 hours of administering zavegepant.