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Recruiting NCT06401642

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

Phase IV Interventional Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zavegepant.
Who it may be relevant to
Registry conditions: Migraine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Zavegepant
    10 mg intranasal

Primary outcome measures

  • Headache relief in 2 hours [Time frame: 2 hours]
  • Headache relief in 4 hours [Time frame: 4 hours]
  • Functional disability level in 2 hours [Time frame: 2 hours]
  • Functional disability level in 4 hours [Time frame: 4 hours]
Secondary outcome measures (3)
  • Adverse events [Time frame: Approximately 24-32 weeks]
  • Serious adverse events [Time frame: Approximately 24-32 weeks]
  • Discontinuation due to adverse events [Time frame: Approximately 24-32 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Arizona — Phoenix

Identifiers

NCT: NCT06401642 · 23-011210

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗