NCT06401642RecruitingPhase 4
Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications
A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 2 May 2024
- Start date
- 22 Mar 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- Mayo Clinic
- Diseases
- Migraine
- NCT number
- NCT06401642
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 22 Mar 2024 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- History of hypersensitivity reaction to rimegepant or to any of the components of rimegepant.
Other
- Participants may have either episodic or chronic migraine.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.