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

A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well zavegepant (Zavzpret) treats migraine attacks and how well people tolerate it. It is for adults who take CGRP-targeting medicines, which help prevent migraines.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Have a migraine diagnosis that meets standard rules, with or without aura. Aura can include changes in vision or other senses.
  • Have 2 to 8 migraine attacks per month.
  • Take one of these CGRP migraine prevention medicines: atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab, or rimegepant.
  • Before zavegepant treatment, have a steady dose of your CGRP medicine for at least 2 months if it is a pill or monthly shot. For shots given every 3 months, have had at least 2 treatments.
  • Other migraine prevention medicines or treatments are allowed if they have stayed the same for at least 2 months before joining.
  • Both episodic and chronic migraine—less frequent or more frequent migraines—are allowed. Past use of zavegepant or other gepants is allowed.
  • If starting rimegepant for prevention, report an average of at least 4 migraine days per month during the 2 months before the screening visit.

Who can't join

  • Have another main headache disorder besides migraine. Tension-type headaches are allowed.
  • Have had an allergic reaction to zavegepant or any of its ingredients.
  • If starting rimegepant for prevention, have had an allergic reaction to rimegepant or any of its ingredients.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

AZ