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

NCT06628921 — Recruiting, 50 participants, University of Florence

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Registry	NCT06628921, acronym BEFREE
Status	Recruiting
Study type	Observational
Enrollment	50 (Estimated)
Sponsor	University of Florence (Other); collaborators: Società Italiana per lo Studio delle Cefalee, Fondazione Policlinico Universitario Campus Bio-Medico, SISC RICe Group
Conditions	Migraine
Interventions	Eptinezumab 100 or 300 mg ev (Drug)
Dates	start 2024-10-30, primary completion 2026-10-30 (estimated), completion 2026-10-30 (estimated), first posted 2024-10-08, last updated 2026-01-21
Locations	1 site in Italy

-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)

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+Arms and interventions

Arm	Type	Interventions	Description
Episodic migraine		Drug: Eptinezumab 100 or 300 mg ev	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.
Chronic migraine		Drug: Eptinezumab 100 or 300 mg ev	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.

Eptinezumab 100 or 300 mg ev (Drug), also known as Eptinezumab: Eptinezumab administered for migraine prevention in patients but with ongoing migraine attacks.

+Outcome measures

Primary outcomes

Time to Headache Pain Freedom [Up to 48 hours postdose]: Time to headache pain freedom defined as the time that the participant reported freedom of pain, meaning their headache pain had gone from moderate to severe at baseline to no pain.

Secondary outcomes

Time to Absence of Most Bothersome Symptom (MBS) [Up to 48 hours postdose]: Time to absence of most bothersome symptom defined as the time that the participant reported absence of MBS
Headache Pain Freedom at 2 Hours [2 hours]: Number of participants with freedom from headache pain at 2 hours postdose are reported.
Absence of MBS at 2 Hours [2 hours]: Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported.
Headache Pain Freedom and absence of MBS [Up to 48 hours postdose]: Number of participants with freedom from headache pain and/or Number of participants with absence of MBS up to 48 hours
Use of Rescue Medication [Up to 48 hours postdose]: Number of participants who used rescue medication up to 48 hours post dose

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Campus Biomedico	Roma	Italy	Recruiting

+Publications

Winner PK, McAllister P, Chakhava G, Ailani J, Ettrup A, Krog Josiassen M, Lindsten A, Mehta L, Cady R. Effects of Intravenous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial. JAMA. 2021 Jun 15;325(23):2348-2356. doi: 10.1001/jama.2021.7665. PMID 34128999