Migraine
Conditions
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.
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.
Interventions
DRUGZavegepant
10 mg intranasal
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache relief in 2 hours | 2 hours | Percentage of participants who have meaningful headache relief within 2 hours of administering zavegepant |
| Headache relief in 4 hours | 4 hours | Percentage of participants who have meaningful headache relief within 4 hours of administering zavegepant |
| Functional disability level in 2 hours | 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 | 4 hours | Percentage of participants with functional disability level of normal or mildly impaired within 4 hours of administering zavegepant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Approximately 24-32 weeks | Percentage of participants and treated migraine attacks with treatment emergent adverse events |
| Serious adverse events | Approximately 24-32 weeks | Percentage of participants and treated migraine attacks with serious treatment emergent adverse events |
| Discontinuation due to adverse events | Approximately 24-32 weeks | Percentage of participants who discontinue zavegepant due to adverse events |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTodd Schwedt, MD
Mayo Clinic
Outcome results
None listed