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Taking people in ItalyNo phase

Studies eptinezumab given during a migraine attack

Checks whether eptinezumab infusion helps end an ongoing migraine attack in adults.

Key facts

Who runs it
University of Florence
Where
Roma, ItalySee the site
Trial code
Registry title
The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
Status
Recruiting
People taking part
50 people, planned
Started
30 Oct 2024
Planned end
30 Oct 2026
Type of study
Observational, 2 groups
Treatments tested
  • Eptinezumab 100 or 300 mg ev
Record updated
21 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with migraine who are about to start eptinezumab and have a migraine attack going on at the time of the infusion.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Migraine without aura, migraine with aura, or chronic migraine, with at least 8 days of migraine per month. An attack must be ongoing before the drug is given.
Earlier treatment
No change in other preventive migraine treatment in the month before starting eptinezumab.

Main reasons for not taking part

  • Contraindications to eptinezumab
  • Other medical conditions that could interfere with the study results, in the investigator's opinion
  • Pregnancy or breastfeeding
  • Not included in the TACHIS study (NCT06409845)
  • No migraine diary for at least one month before enrollment

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Concomitant diagnosis of medical conditions and/or comorbidities that, in the investigator's opinion, could interfere with the study's assessments and outcomes
  • Changes in concomitant preventive therapy in the month prior to the initiation of eptinezumab
  • Subjects with contraindications to the use of eptinezumab
  • Pregnancy and breastfeeding

Where in Italy

  • Campus BiomedicoRoma, ItalyContact: Fabrizio Vernieri, MDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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)

The 2 groups in the trial

  • 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.

    Treatment: Eptinezumab 100 or 300 mg ev

  • 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.

    Treatment: Eptinezumab 100 or 300 mg ev

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
Plain-language title
Studies eptinezumab given during a migraine attackGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
21 January 2026