Clinical trial NCT06401642: Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications
Official title: A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Headache relief in 2 hours
timeFrame: 2 hours
measure: Headache relief in 4 hours
timeFrame: 4 hours
measure: Functional disability level in 2 hours
timeFrame: 2 hours
measure: Functional disability level in 4 hours
timeFrame: 4 hours
Secondary outcomes:
measure: Adverse events
timeFrame: Approximately 24-32 weeks
measure: Serious adverse events
timeFrame: Approximately 24-32 weeks
measure: Discontinuation due to adverse events
timeFrame: Approximately 24-32 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Todd Schwedt, MD
role: PRINCIPAL_INVESTIGATOR
References: