MigrainePhase 4NCT06401642
Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications
A Phase 4 study testing Zavegepant in people with Migraine, run by Mayo Clinic at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Zavegepant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- Erenumab
- Fremanezumab
- Galcanezumab
- Rimegepant
- 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.
Who cannot join
- 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
- History of hypersensitivity reaction to rimegepant or to any of the components of rimegepant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Phoenix, Arizona, 85254
Michael R Leonard, 480-342-2908, Leonard.Michael@Mayo.edu
Dani SMith, 480-342-6524, Smith.Dani@mayo.edu
About this study
Official title: A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.
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.
Read the detailed description
This is a phase IV, open-label, prospective, longitudinal clinical trial of intranasal zavegepant 10 mg, a CGRP receptor antagonist, for the acute treatment of migraine attacks amongst individuals who are concomitantly taking stable doses of CGRP targeting migraine preventive treatment (atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab, rimegepant). The effectiveness and tolerability of zavegepant will be assessed in this specific participant population. Participants who are not already taking a CGRP-targeting migraine preventive treatment but who meet criteria for migraine prevention according to their clinician's discretion, will have the option to start rimegepant 75 mg every other day (qod) for two months. After two months, continued eligibility for participation in the clinical trial of zavegepant will be assessed. Those receiving rimegepant for migraine prevention through their participation in this study will have the option to receive rimegepant for up to 32 consecutive weeks.
- Conditions
- Migraine
- Being tested
- Zavegepant
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZavegepantDrug
10 mg intranasal
| Study group | Role | What they receive |
|---|---|---|
| Zavegepant Treatment | Experimental | Participants will receive zavegepant to treat up to 8 migraine attacks over 24 weeks. Receives: Drug: Zavegepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache relief in 2 hours
Percentage of participants who have meaningful headache relief within 2 hours of administering zavegepant
Measured: 2 hours
Headache relief in 4 hours
Percentage of participants who have meaningful headache relief within 4 hours of administering zavegepant
Measured: 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.
Measured: 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.
Measured: 4 hours
Secondary outcomes (3)
Adverse events
Percentage of participants and treated migraine attacks with treatment emergent adverse events
Measured: Approximately 24-32 weeks
Serious adverse events
Percentage of participants and treated migraine attacks with serious treatment emergent adverse events
Measured: Approximately 24-32 weeks
Discontinuation due to adverse events
Percentage of participants who discontinue zavegepant due to adverse events
Measured: Approximately 24-32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start22 Mar 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd J. Schwedt, Mayo Clinic
- Investigators
- Todd Schwedt, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401642
- Sponsor's protocol ID
- 23-011210
- Status last verified
- Sep 2026
- First submitted
- 2 May 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.
- ClinicalTrials.gov ID
- NCT06401642
- Acronym / sponsor ID
- 23-011210
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase IV, open-label, prospective, longitudinal clinical trial of intranasal zavegepant 10 mg, a CGRP receptor antagonist, for the acute treatment of migraine attacks amongst individuals who are concomitantly taking stable doses of CGRP targeting migraine preventive treatment (atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab, rimegepant). The effectiveness and tolerability of zavegepant will be assessed in this specific participant population. Participants who are not already taking a CGRP-targeting migraine preventive treatment but who meet criteria for migraine prevention according to their clinician's discretion, will have the option to start rimegepant 75 mg every other day (qod) for two months. After two months, continued eligibility for participation in the clinical trial of zavegepant will be assessed. Those receiving rimegepant for migraine prevention through their participation in this study will have the option to receive rimegepant for up to 32 consecutive weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zavegepant Treatment | Experimental | Drug: ZavegepantParticipants will receive zavegepant to treat up to 8 migraine attacks over 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zavegepant10 mg intranasal | Drug | Zavegepant Treatment |
Primary outcome
Headache relief in 2 hours
Time frame: 2 hours
Percentage of participants who have meaningful headache relief within 2 hours of administering zavegepant
Headache relief in 4 hours
Time frame: 4 hours
Percentage of participants who have meaningful headache relief within 4 hours of administering zavegepant
Functional disability level in 2 hours
Time frame: 2 hours
Percentage of participants with functional disability level of normal or mildly impaired within 2 hours of administering zavegepant.
Functional disability level in 4 hours
Time frame: 4 hours
Percentage of participants with functional disability level of normal or mildly impaired within 4 hours of administering zavegepant.
3 secondary outcomes
Adverse events
Time frame: Approximately 24-32 weeks
Serious adverse events
Time frame: Approximately 24-32 weeks
Discontinuation due to adverse events
Time frame: Approximately 24-32 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Zavegepant to Treat Migraine AttacksLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Todd Schwedt, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zavegepant in people with Migraine, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache relief in 2 hours (time frame: 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.