MigraineBEFREENCT06628921
The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
An observational study of Migraine, run by University of Florence at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Eptinezumab 100 or 300 mg ev
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2024to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for eptinezumab use as migraine preventive treatment
Who may be able to join
- 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 join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this 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)
- Conditions
- Migraine
- Being tested
- Eptinezumab 100 or 300 mg ev
- Keywords
- headache, Pain, migraine, Eptinezumab
- Medical subject headings
- Migraine Disorders, Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eptinezumab 100 or 300 mg evDrug
Also called Eptinezumab
Eptinezumab administered for migraine prevention in patients but with ongoing migraine attacks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Eptinezumab 100 or 300 mg ev |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 48 hours postdose
Secondary outcomes (5)
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
Measured: Up to 48 hours postdose
Headache Pain Freedom at 2 Hours
Number of participants with freedom from headache pain at 2 hours postdose are reported.
Measured: 2 hours
Absence of MBS at 2 Hours
Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported.
Measured: 2 hours
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
Measured: Up to 48 hours postdose
Use of Rescue Medication
Number of participants who used rescue medication up to 48 hours post dose
Measured: Up to 48 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start30 Oct 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- Società Italiana per lo Studio delle Cefalee, Fondazione Policlinico Universitario Campus Bio-Medico, SISC RICe Group
- Responsible party
- Principal investigator, Luigi Francesco Iannone, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628921
- Sponsor's protocol ID
- Rice_5.1
- Acronym
- BEFREE
- Status last verified
- Jan 2026
- First submitted
- 3 Oct 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
- ClinicalTrials.gov ID
- NCT06628921
- Acronym / sponsor ID
- BEFREE / Rice_5.1
- Conditions
- Migraine
- Keywords
- headache, Pain, migraine, Eptinezumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- Società Italiana per lo Studio delle Cefalee, Fondazione Policlinico Universitario Campus Bio-Medico, SISC RICe Group
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Episodic migraine | – | Drug: Eptinezumab 100 or 300 mg evPatients affected by migraine with an episodic pattern (< 15 monthly migraine days) with or without aura according to ICHD-III criteria with ongoing migraine attack. |
| Chronic migraine | – | Drug: Eptinezumab 100 or 300 mg evGroup/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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for eptinezumab use as migraine preventive treatment
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eptinezumab 100 or 300 mg evAlso: EptinezumabEptinezumab administered for migraine prevention in patients but with ongoing migraine attacks. | Drug | Chronic migraine, Episodic migraine |
Primary outcome
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.
5 secondary outcomes
Time to Absence of Most Bothersome Symptom (MBS)
Time frame: Up to 48 hours postdose
Headache Pain Freedom at 2 Hours
Time frame: 2 hours
Absence of MBS at 2 Hours
Time frame: 2 hours
Headache Pain Freedom and absence of MBS
Time frame: Up to 48 hours postdose
Use of Rescue Medication
Time frame: Up to 48 hours postdose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 34128999Winner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by University of Florence at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio Vernieri, MD (06 225411, F.Vernieri@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Headache Pain Freedom (time frame: Up to 48 hours postdose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06628921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.