Recruiting

Zavegepant

Sponsor:

Mayo Clinic

Code:

NCT06401642

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zavegepant

Study Details

Brief 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.

Conditions

Migraine

Study ID

NCT06401642

Start date

Mar 22, 2024

Status verified date

Sep, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zavegepant Treatment

Participants will receive zavegepant to treat up to 8 migraine attacks over 24 weeks.

Interventions

Zavegepant

10 mg intranasal

Primary outcome measure

  • Headache relief in 2 hours [ Time Frame: 2 hours ]
  • Headache relief in 4 hours [ Time Frame: 4 hours ]
  • Functional disability level in 2 hours [ Time Frame: 2 hours ]
  • Functional disability level in 4 hours [ Time Frame: 4 hours ]

Central Contacts and Locations

Locations

Mayo Clinic in Arizona

Recruiting

Phoenix, Arizona, United States, 85254

Contacts

Principal Investigator:

Todd J Schwedt, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-09-09.