NCT06401642

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
10mo left

Started Mar 2024

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Mar 2024Mar 2027

Study Start

First participant enrolled

March 22, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

2.9 years

First QC Date

May 2, 2024

Last Update Submit

September 3, 2025

Conditions

Migraine

Outcome Measures

Primary Outcomes (4)

  • Headache relief in 2 hours

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

    2 hours

  • Headache relief in 4 hours

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

    4 hours

  • Functional disability level in 2 hours

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

    2 hours

  • Functional disability level in 4 hours

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

    4 hours

Secondary Outcomes (3)

  • Adverse events

    Approximately 24-32 weeks

  • Serious adverse events

    Approximately 24-32 weeks

  • Discontinuation due to adverse events

    Approximately 24-32 weeks

Study Arms (1)

Zavegepant Treatment

EXPERIMENTAL

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

Drug: Zavegepant

Interventions

ZavegepantDRUG

10 mg intranasal

Zavegepant Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • 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
  • 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.
  • History of hypersensitivity reaction to rimegepant or to any of the components of rimegepant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85254, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Todd Schwedt, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 7, 2024

Study Start

March 22, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)