Clinical Trials

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.