Eptinezumab given during a migraine attack (BE-FREE)
The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florence Academic / other |
| Drugs / interventions | eptinezumab |
| Locations | 1 site (Roma) |
| Trial ID | NCT06628921 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma
- Campus Biomedico — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Fabrizio Vernieri, MD
- Email: F.Vernieri@policlinicocampus.it
- Phone: 06 225411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.