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

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)

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: Eptinezumab 100 or 300 mg ev

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Fabrizio Vernieri, MD; Phone Number: 06 225411; Email: F.Vernieri@policlinicocampus.it

Study Locations

• Italy
  • Roma, Italy
    • Recruiting
    • Campus Biomedico
    • Contact: Fabrizio Vernieri, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for eptinezumab use as migraine preventive treatment

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Episodic migraine; 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.	Drug: Eptinezumab 100 or 300 mg ev; Eptinezumab administered for migraine prevention in patients but with ongoing migraine attacks.; Other Names: Eptinezumab
Chronic migraine; 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.	Drug: Eptinezumab 100 or 300 mg ev; Eptinezumab administered for migraine prevention in patients but with ongoing migraine attacks.; Other Names: Eptinezumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Headache Pain Freedom	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.	Up to 48 hours postdose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Florence
• Collaborators: Fondazione Policlinico Universitario Campus Bio-Medico; SISC RICe Group; Società Italiana per lo Studio delle Cefalee

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pain; headache; migraine; Eptinezumab
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Migraine Disorders; Headache; eptinezumab
• Other Study ID Numbers: Rice_5.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No