RECRUITINGOBSERVATIONAL

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

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)

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Eptinezumab 100 or 300 mg ev

Eptinezumab administered for migraine prevention in patients but with ongoing migraine attacks.

Locations (1)

Campus Biomedico

Roma, Italy