Using Zavegepant to treat acute migraines in patients on preventive medications
A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.
This study is testing if a nasal spray called zavegepant can help people with migraines who are already taking preventive medications feel better during their migraine attacks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | Eptinezumab, Erenumab, Fremanezumab, Galcanezumab |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT06401642 on ClinicalTrials.gov |
What this trial studies
This phase IV clinical trial investigates the effectiveness and tolerability of intranasal zavegepant 10 mg for treating acute migraine attacks in individuals already using calcitonin gene-related peptide (CGRP) preventive treatments. Participants must be on stable doses of CGRP-targeting medications for at least two months prior to treatment. The study aims to assess how well zavegepant works in this specific population, with options for participants not currently on CGRP treatments to start rimegepant for migraine prevention. The trial will monitor the outcomes over a defined period to evaluate the benefits of zavegepant.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who experience 2-8 migraine attacks per month and are currently on stable doses of CGRP-targeting preventive medications.
Not a fit: Patients with primary headache disorders other than migraine or those with a history of hypersensitivity to zavegepant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for acute migraine relief in patients already using preventive therapies.
How similar studies have performed: Other studies have shown positive outcomes with CGRP-targeting treatments, suggesting a promising approach for this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Phoenix, Arizona
- Mayo Clinic in Arizona — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Todd Schwedt, MD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.