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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06401642
• Other study ID #: 23-011210
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2024
• Est. completion date: March 2027

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Zavegepant
10 mg intranasal

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache relief in 2 hours	Percentage of participants who have meaningful headache relief within 2 hours of administering zavegepant	2 hours
Primary	Headache relief in 4 hours	Percentage of participants who have meaningful headache relief within 4 hours of administering zavegepant	4 hours
Primary	Functional disability level in 2 hours	Percentage of participants with functional disability level of normal or mildly impaired within 2 hours of administering zavegepant.	2 hours
Primary	Functional disability level in 4 hours	Percentage of participants with functional disability level of normal or mildly impaired within 4 hours of administering zavegepant.	4 hours
Secondary	Adverse events	Percentage of participants and treated migraine attacks with treatment emergent adverse events	Approximately 24-32 weeks
Secondary	Serious adverse events	Percentage of participants and treated migraine attacks with serious treatment emergent adverse events	Approximately 24-32 weeks
Secondary	Discontinuation due to adverse events	Percentage of participants who discontinue zavegepant due to adverse events	Approximately 24-32 weeks

External Links

•   Mayo Clinic Clinical Trials