Eptinezumab given during a migraine attack (BE-FREE)
Official title: The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
Run by University of Florence · NCT06628921 · Data updated 2026-11-12
This will test whether an IV dose of eptinezumab can stop an ongoing migraine attack in people who have at least eight migraine days per month.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Florence Academic / other |
| Drugs / interventions | eptinezumab |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | October 30, 2024 |
| Main results expected | October 30, 2026 |
| Study ends | October 30, 2026 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT06628921 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with migraine (per ICHD-III) who have at least eight migraine days per month, are enrolled in the TACHIS registry, and are experiencing an ongoing attack at the time of infusion.
✕Probably not a fit
People with contraindications to eptinezumab, those who are pregnant or breastfeeding, patients who recently changed preventive therapy, or individuals not having an active migraine at infusion are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational study follows patients who start eptinezumab as part of routine care and are also enrolled in the TACHIS registry. Participants receive a single intravenous infusion of eptinezumab 100 mg or 300 mg during an ongoing migraine attack, and investigators record whether and how quickly the headache resolves. The protocol builds on reports from the RELIEF trial that some patients experience rapid resolution during infusion and aims to measure that effect in a real-world setting. Data are collected across participating Italian centers to describe time to pain relief and related clinical outcomes.
Why it matters
Potential benefit: If successful, this could provide a rapid, in-clinic option to stop some migraine attacks with a single IV dose.
How similar studies have gone: Prior work including the RELIEF trial has reported rapid symptom resolution during eptinezumab infusion, so this approach has some supporting evidence though it is being confirmed in routine practice.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the third edition of the ICHD (ICHD-III). * At least 8 days of migraine per month. * Adequate compliance with study procedures. * Availability of a migraine diary for at least one month prior to enrollment. * Ongoing attack before administration. * Included in the TACHIS study (NCT06409845) Exclusion Criteria: * Subjects with contraindications to the use of eptinezumab. * Concomitant diagnosis of medical conditions and/or comorbidities that, in the investigator's opinion, could interfere with the study's assessments and outcomes. * Pregnancy and breastfeeding. * Changes in concomitant preventive therapy in the month prior to the initiation of eptinezumab.
Where it's running
-
Campus Biomedico
Roma, Italy Recruiting
Study contacts
- Study coordinator: Fabrizio Vernieri, MD
- Email: F.Vernieri@policlinicocampus.it
- Phone: 06 225411
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.