The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
ConditionMigraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Florence
About this trial
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)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Eptinezumab 100 or 300 mg ev
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Florence
Lead sponsor
Società Italiana per lo Studio delle Cefalee
Collaborator
Fondazione Policlinico Universitario Campus Bio-Medico
Collaborator
SISC RICe Group
Collaborator
Source ClinicalTrials.gov