Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications

Mayo Clinic

Status and phase

Enrolling

Phase 4

Conditions

Migraine

Treatments

Drug: Zavegepant

Study type

Interventional

Funder types

Other

Identifiers

NCT06401642

23-011210

Details and patient eligibility

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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.