Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401642
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-02
Brief Title:
Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 clinicians 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None