NCT06401642 · Mayo Clinic
Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Zavegepant
10 mg intranasal
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Eptinezumab
- Fremanezumab
- Galcanezumab
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.
Where
- Phoenix, Arizona
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2025 · Source of record for eligibility and locations