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RecruitingNCT06628921BEFREEUpdated Jan 21, 2026

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

An observational study in Migraine, sponsored by University of Florence. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by University of Florence · Observational

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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)

02

Conditions studied

  • Migraine

Keywords

  • headache
  • Pain
  • migraine
  • Eptinezumab
03

In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 50 is below the median of 137 across 331 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

University of Florence is the lead sponsor of 76 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Subjects with 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

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

    Also known as: Eptinezumab

06

What researchers measure

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

  5. Use of Rescue Medication

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

    Time frame: Up to 48 hours postdose

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 34128999 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Oct 2026, 24 months after the start.

Of 132 non-industry observational studies under Migraine Disorders, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 72. This study's planned 24 months is below that.

Counting every sponsor, half of 160 studies reached it within 27 months; a quarter within 13 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2024
First posted
Oct 8, 2024
StartActual
Oct 30, 2024
Primary completionEst.
Oct 30, 2026
CompletionEst.
Oct 30, 2026
Last update
Jan 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06628921
Lead sponsor
University of Florence
Collaborators
Società Italiana per lo Studio delle Cefalee, Fondazione Policlinico Universitario Campus Bio-Medico, SISC RICe Group
Responsible party
Luigi Francesco Iannone (Researcher, University of Florence) — Principal investigator
First posted
Oct 8, 2024
Start date
Oct 30, 2024
Primary completion
Oct 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Jan 21, 2026

Study contacts

Fabrizio Vernieri, MD
Contact
F.Vernieri@policlinicocampus.it
06 225411

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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