The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study) (BEFREE)

University of Florence (UNIFI)

Status: Enrolling

Conditions: Migraine

Treatments: Drug: Eptinezumab 100 or 300 mg ev

Study type: Observational

Funder types: Other

Identifiers

NCT06628921

Rice_5.1

Details and patient eligibility

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)

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

Episodic migraine

Description:

Patients affected by migraine with an episodic pattern (\< 15 monthly migraine days) with or without aura according to ICHD-III criteria with ongoing migraine attack.

Treatment:

Drug: Eptinezumab 100 or 300 mg ev

Chronic migraine

Description:

Group/Cohort Description: atients affected by chronic migraine (\> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria with ongoing migraine attack.

Treatment:

Drug: Eptinezumab 100 or 300 mg ev