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

Phase 4

Recruiting

• Conditions: Migraine
• Interventions: Drug: Zavegepant

• Registration Number: NCT06401642
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2024-03-22
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-02
• Study First Posted: 2024-05-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zavegepant Treatment	Zavegepant	Participants will receive zavegepant to treat up to 8 migraine attacks over 24 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Phoenix, Arizona, United States