Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications
- Conditions
- Migraine
- Registration Number
- NCT06401642
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria<br><br> - Meets International Classification of Headache Disorders 3 (ICHD-3) diagnostic<br> criteria for migraine with or without aura<br><br> - At least 18 years of age<br><br> - 2- 8 migraine attacks per month<br><br> - Participants should be on a calcitonin gene-related peptide (CGRP)-targeting<br> preventive migraine medication on a stable dose for a) =2 months prior to zavegepant<br> treatment if an oral gepant or a monoclonal antibody (mAb) injected monthly, or b)<br> at least two treatments if a mAb injected each 3 months.<br><br> - Atogepant<br><br> - Eptinezumab<br><br> - Erenumab<br><br> - Fremanezumab<br><br> - Galcanezumab<br><br> - Rimegepant<br><br>Exclusion Criteria<br><br> - Primary headache disorders other than migraine (tension-type headache days are<br> allowed)<br><br> - History of hypersensitivity reaction to zavegepant or to any of the components of<br> zavegepant<br><br>Eligibility Notes<br><br> - Participants may have either episodic or chronic migraine.<br><br> - Prior use of zavegepant and other gepants is permitted.<br><br> - Participants can be using migraine preventive medications/treatments in addition to<br> the CGRP-targeting preventive treatment, as long as those treatments have been<br> stable for at least two months at the time of enrollment.<br><br>Additional Eligibility Criteria for Participants to Start on Rimegepant for Migraine<br>Prevention<br><br>Inclusion Criteria:<br><br>• Must have 4 or more migraine days per month, on average, during the 2 months prior to<br>the Screening Visit, according to participant self-report.<br><br>Exclusion Criteria<br><br>• History of hypersensitivity reaction to rimegepant or to any of the components of<br>rimegepant.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Headache relief in 2 hours;Headache relief in 4 hours;Functional disability level in 2 hours;Functional disability level in 4 hours
- Secondary Outcome Measures
Name Time Method Adverse events;Serious adverse events;Discontinuation due to adverse events