Actively Recruiting
The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
Led by University of Florence · Updated on 2026-01-21
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Florence
Lead Sponsor
S
Società Italiana per lo Studio delle Cefalee
Collaborating Sponsor
AI-Summary
What this Trial Is About
A perspective and multicentric study to evaluate the efficacy of eptinezumab administered during a migraine attack. During the intravenous infusion of eptinezumab, some patients experiencing an ongoing migraine attack report its resolution. This finding is known in the literature, having been described in the RELIEF study. This study was designed to also evaluate, in a real-world setting, the efficacy of eptinezumab in resolving the ongoing attack and the time frame within which the attack is resolved. The study includes all patients who will begin treatment according to clinical practice, and are included in the TACHIS study (NCT06409845, Unique protocol ID RICe\_5)
CONDITIONS
Official Title
The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- Subjects with contraindications to the use of eptinezumab
- Concomitant diagnosis of medical conditions and/or comorbidities that 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Campus Biomedico
Roma, Italy
Actively Recruiting
Research Team
F
Fabrizio Vernieri, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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