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

ConditionMigraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Florence

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Eptinezumab 100 or 300 mg ev

    Drug

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Episodic migraine1 intervention
Group B: Chronic migraine1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 48 hours postdose

Secondary outcomes

1

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

Time frame
Up to 48 hours postdose
2

Headache Pain Freedom at 2 Hours

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

Time frame
2 hours
3

Absence of MBS at 2 Hours

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

Time frame
2 hours
4

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

Time frame
Up to 48 hours postdose

Other outcomes

Sponsors and contacts

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University of Florence

Lead sponsor

Società Italiana per lo Studio delle Cefalee

Collaborator

Fondazione Policlinico Universitario Campus Bio-Medico

Collaborator

SISC RICe Group

Collaborator

Source ClinicalTrials.gov
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