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

NCT ID: NCT06628921

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2026-10-30

Brief 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)

Conditions

Migraine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Eptinezumab 100 or 300 mg ev

Intervention Type: DRUG

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

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.

Eptinezumab 100 or 300 mg ev

Intervention Type: DRUG

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

Interventions

Eptinezumab 100 or 300 mg ev

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

Intervention Type: DRUG

Other Intervention Names

Eptinezumab

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Società Italiana per lo Studio delle Cefalee

OTHER

Sponsor Role: collaborator

Fondazione Policlinico Universitario Campus Bio-Medico

OTHER

Sponsor Role: collaborator

SISC RICe Group

UNKNOWN

Sponsor Role: collaborator

University of Florence

OTHER

Sponsor Role: lead

Responsible Party

Luigi Francesco Iannone

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Campus Biomedico

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fabrizio Vernieri, MD

Role: CONTACT

F.Vernieri@policlinicocampus.it

06 225411

Facility Contacts

Fabrizio Vernieri, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 34128999 (View on PubMed)

Other Identifiers

Rice_5.1

Identifier Type: -

Identifier Source: org_study_id