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NCT Number: NCT06628921

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

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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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Campus Biomedico

Roma, Italy

Location status: Recruiting

Location contact

Fabrizio Vernieri, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eptinezumab 100 or 300 mg ev

Drug

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

Other names: Eptinezumab

Primary outcomes

  1. Time to Headache Pain Freedom

    Time frame: 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

  1. Time to Absence of Most Bothersome Symptom (MBS)

    Time frame: Up to 48 hours postdose

    Time to absence of most bothersome symptom defined as the time that the participant reported absence of MBS

  2. Headache Pain Freedom at 2 Hours

    Time frame: 2 hours

    Number of participants with freedom from headache pain at 2 hours postdose are reported.

  3. Absence of MBS at 2 Hours

    Time frame: 2 hours

    Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported.

  4. Headache Pain Freedom and absence of MBS

    Time frame: 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

  5. Use of Rescue Medication

    Time frame: Up to 48 hours postdose

    Number of participants who used rescue medication up to 48 hours post dose

Study contacts

Contact information is provided by the study sponsor or research team.

Fabrizio Vernieri, MD

CONTACT

[email protected]

06 225411

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Collaborators

  • Fondazione Policlinico Universitario Campus Bio-Medico
  • SISC RICe Group
  • Società Italiana per lo Studio delle Cefalee

Registry information

Acronym: BEFREE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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