RecruitingNCT06628921

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


Sponsor

University of Florence

Enrollment

50 participants

Start Date

Oct 30, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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.

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Interventions

DRUGEptinezumab 100 or 300 mg ev

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


Locations(1)

Campus Biomedico

Roma, Italy

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NCT06628921


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