NCT06401642 Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications
| NCT ID | NCT06401642 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mayo Clinic |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-03-22 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2024-03-22 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Todd Schwedt, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06401642 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06401642 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06401642 currently recruiting?
Yes, NCT06401642 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT06401642 trial being conducted?
This trial is being conducted at Phoenix, United States.
Who is sponsoring the NCT06401642 clinical trial?
NCT06401642 is sponsored by Mayo Clinic. The principal investigator is Todd Schwedt, MD at Mayo Clinic. The trial plans to enroll 200 participants.
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