Zavegepant to Treat Migraine Attacks Amongst Those Using Preventive Medication

Overview

About this study

The purpose of this study is to determine the effectiveness of intranasal zavegepant 10 mg for the acute treatment of migraine attacks when used by those also taking CGRP targeted migraine preventive medications.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Meets ICHD 3 diagnostic criteria for migraine with or without aura
  • Migraine onset before age 50 years
  • Migraine for at least one year at the time of enrollment
  • At least 18 years of age
  • 2- 8 migraine attacks per month
  • Participants should be on a CGRP-targeting preventive migraine medication on a stable dose for ≥2 months prior to screening visit
    • Atogepant
    • Eptinezumab
    • Erenumab
    • Fremanezumab
    • Galcanezumab
    • Rimegepant
  • Women must not be pregnant, lactating or breastfeeding.
  • All participants must understand the contraception requirements and agree to use two acceptable methods of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized
  • Ability to fill an e-diary

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
  • History of use of narcotic or barbiturate containing medications, including opioids (eg, morphine, codeine, oxycodone and hydrocodone) on ≥5 days per month on a regular basis for ≥3 months prior to randomization.
  • Current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, uncontrolled hypertension or uncontrolled diabetes
  • Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.
  • Severe hepatic impairment
  • Stage 4 renal disease (CLcr<30 mL/min)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/27/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Todd Schwedt, M.D.

Open for enrollment

Contact information:

Michael Leonard CCRP

(480) 342-2908

Leonard.Michael@mayo.edu

More information

Publications

Publications are currently not available