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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-22

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Migraine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zavegepant Treatment

Participants will receive zavegepant to treat up to 8 migraine attacks over 24 weeks.

Group Type EXPERIMENTAL

Zavegepant

Intervention Type DRUG

10 mg intranasal

Interventions

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Zavegepant

10 mg intranasal

Intervention Type DRUG

Eligibility Criteria

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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

• 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

* 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

• History of hypersensitivity reaction to rimegepant or to any of the components of rimegepant.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No