The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
Recruiting · NCT06628921 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Florence
View the official record on ClinicalTrials.gov →Interventions studied
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)
Who can take part
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 is running
1 location listed.
- Campus Biomedico - Roma, Italy