Migraine DisordersEMBRACENCT05570149
EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.
An observational study of Migraine Disorders, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 31 Dec 2026
- How long will I take part?
- 3 Years
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all consecutive patients aged 18-75 affected by hight frequency or chronic migraine with or without medication overuse.
Who may be able to join
- Age between 18 and 75 years;
- Males and females;
- Willingness to sign the informed consent;
- High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months;
- Chronic migraine, according to the ICHD-III criteria;
Who cannot join
- Other headaches different than migraine;
- Known intolerance to eptinezumab or eccipients;
- Current treatment with other mAbs;
- Vascular disease or Raynaud.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Roma
Roma, RM, 00163
Piero Barbanti, MD, PhD, 0652254026, piero.barbanti@sanraffaele.it
Cinzia Aurilia, MD, 0652254026, cinzia.aurilia@sanraffaele.it
About this study
Official title: EptinezuMaB in ReAl-world evidenCE: a 12-Months, Multicenter, Real-Life, Cohort Study in High-Frequency Episodic and Chronic Migraine (the EMBRACE Study)
The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.
Read the detailed description
Eptinezumab is an humanized IgG1 and the only antiCGRP mAb administered intravenously by a quarterly dosing regimen. In randomized-controlled studies (RCTs), eptinezumab proved to be effective in preventing episodic and chronic migraine even in patients with 2 to 4 prior preventive failures and in shortening the time to complete migraine freedom when infused during a moderate-to severe migraine attack. Eptinezumab 100 mg can be used for the first administration and later if deemed necessary, the dose upgraded to 300 mg.
EMBRACE is a multicenter, prospective, cohort, real-life study carried out in Italian headache centers. Consecutive patients with high frequency episodic (HFEM: ≥8 migraine days/month) or CM (≥15 headache days/month), according to The International Classification of Headache Disorders, 3rd edition (ICHD-III), referred to participating centers. The aim of this study is to assess effectiveness, safety and tolerability of eptinezumab 100 mg iv or 300 mg iv with a quarterly dosing regimen in a real-world migraine patients population.
- Conditions
- Migraine Disorders
- Being tested
- Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution
- Keywords
- Eptinezumab,, Calcitonin gene-related peptide,, Effectiveness,, Real-life,, Migraine,, Safety, Treatment
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solutionDrug
Also called anti CGRP monoclonal antibody
migraine prophylaxis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;
assessment of MMD or MHD
Measured: over 12 weeks of treatment compared to baseline
Change from baseline in MMD in HFEM or MHD in CM;
assessment of MMD or MHD
Measured: over 24 weeks of treatment compared to baseline
Change from baseline in MMD in HFEM or MHD in CM;
assessment of MMD or MHD
Measured: over 48 weeks of treatment compared to baseline
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
assessment of occurrence of Treatment-Emergent Adverse Events
Measured: over 12 months of treatment compared to baseline
Secondary outcomes (26)
Change in monthly analgesic intake
Assessment of monthly analgesic intake
Measured: over 12 weeks compared to baseline
Change in monthly analgesic intake
Assessment of monthly analgesic intake
Measured: over 24 weeks compared to baseline
Change in monthly analgesic intake
Assessment of monthly analgesic intake
Measured: over 48 weeks compared to baseline
Change in Numeric Rating Scale (NRS)
Assessment of NRS
Measured: over 12 weeks compared to baseline
Change in Numeric Rating Scale (NRS)
Assessment of NRS
Measured: over 24 weeks compared to baseline
Change in Numeric Rating Scale (NRS)
Assessment of NRS
Measured: over 48 weeks compared to baseline
Change in Headache Impact Test-6 (HIT-6)
Assessment of HIT-6
Measured: over 12 weeks compared to baseline
Change in Headache Impact Test-6 (HIT-6)
Assessment of HIT-6
Measured: over 24 weeks compared to baseline
Change in Headache Impact Test-6 (HIT-6)
Assessment of HIT-6
Measured: over 48 weeks compared to baseline
Change in Migraine Disability Assessment Score (MIDAS)
Assessment of MIDAS
Measured: over 12 weeks compared to baseline
Change in Migraine Disability Assessment Score (MIDAS)
Assessment of MIDAS
Measured: over 24 weeks compared to baseline
Change in Migraine Disability Assessment Score (MIDAS)
Assessment of MIDAS
Measured: over 48 weeks compared to baseline
Change in Migraine interictal burden (MIBS-4)
Assessment of MIBS-4
Measured: over 12 weeks compared to baseline
Change in Migraine interictal burden (MIBS-4)
Assessment of MIBS-4
Measured: over 24 weeks compared to baseline
Change in Migraine interictal burden (MIBS-4)
Assessment of MIBS
Measured: over 48 weeks compared to baseline
Change in Patient Global Impression of change (PGIC) scale
Assessment of MIBS
Measured: over 12 weeks compared to baseline
Change in Patient Global Impression of change (PGIC) scale
Assessment of MIBS
Measured: over 24 weeks compared to baseline
Change in Patient Global Impression of change (PGIC) scale
Assessment of MIBS
Measured: over 48 weeks compared to baseline
≥50%, ≥75% and 100% response rates
Assessment of responder rates
Measured: over 12 weeks compared to baseline
≥50%, ≥75% and 100% response rates
Assessment of responder rates
Measured: over 24 weeks compared to baseline
≥50%, ≥75% and 100% response rates
Assessment of responder rates
Measured: over 48 weeks compared to baseline
Percentage of migraine free patients on the day after dosing (infusion of eptinezumab)
Assessment of percentage of migraine free patients on the day after dosing (first infusion of eptinezumab)
Measured: the day after infusion of eptinezumab (first infusion of eptinezumab)
Percentage of migraine free patients on the day after dosing (infusion of eptinezumab)
Assessment of percentage of migraine free patients on the day after dosing (second infusion of eptinezumab)
Measured: the day after infusion of eptinezumab (second infusion of eptinezumab)
Proportion of patients with medication overuse at baseline reverting to no medication overuse
Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse
Measured: over 12 weeks compared to baseline
Proportion of patients with medication overuse at baseline reverting to no medication overuse
Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse
Measured: over 24 weeks compared to baseline
Proportion of patients with medication overuse at baseline reverting to no medication overuse
Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse
Measured: over 48 weeks compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies 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
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piero Barbanti, MD, PhD, Study chair, IRCCS San Raffaele Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570149
- Sponsor's protocol ID
- RP 177/SR/24
- Acronym
- EMBRACE
- Status last verified
- Apr 2025
- First submitted
- 4 Oct 2022
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villar-Martinez MD, Moreno-Ajona D, Goadsby PJ. Eptinezumab for the preventive treatment of migraine. Pain Manag. 2021 Mar;11(2):113-121. doi: 10.2217/pmt-2020-0075. Epub 2020 Dec 7.
PubMed 33280422Lipton RB, Goadsby PJ, Smith J, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Cady R. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar 31;94(13):e1365-e1377. doi: 10.1212/WNL.0000000000009169. Epub 2020 Mar 24.
PubMed 32209650Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.
PubMed 35716692Ashina M, Saper J, Cady R, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Smith J. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020 Mar;40(3):241-254. doi: 10.1177/0333102420905132. Epub 2020 Feb 19.
PubMed 32075406Barbanti P, Aurilia C, Filippi M, Doretti A, d'Onofrio F, Scatena P, Vecchio R, Messina R, Vinciguerra L, Ranieri A, Baldisseri F, Torelli P, Russo M, Cutrona C, Viticchi G, Egeo G, Autunno M, Pistoia F, Finocchi C, Camarda C, Messina S, Rinalduzzi S, Drago V, Caputi L, Bandettini di Poggio M, Quintana S, Salerno A, Bartolini M, Fiorentini G, Spieckert de Souza J, Di Stani F, Bonassi S, Porreca A; Italian Migraine Registry Study Group. Real-World Response and Super-Response to Eptinezumab over 48 Weeks in Migraine: The Prospective Multicenter EMBRACE III Study. Neurol Ther. 2026 Jun 9. doi: 10.1007/s40120-026-00971-7. Online ahead of print.
PubMed 42262724
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EptinezuMaB in ReAl-world evidenCE: a 12-Months, Multicenter, Real-Life, Cohort Study in High-Frequency Episodic and Chronic Migraine (the EMBRACE Study)
- ClinicalTrials.gov ID
- NCT05570149
- Acronym / sponsor ID
- EMBRACE / RP 177/SR/24
- Conditions
- Migraine Disorders
- Keywords
- Eptinezumab,, Calcitonin gene-related peptide,, Effectiveness,, Real-life,, Migraine,, Safety, Treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Oct 2022 (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.
The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.
Detailed description
Eptinezumab is an humanized IgG1 and the only antiCGRP mAb administered intravenously by a quarterly dosing regimen. In randomized-controlled studies (RCTs), eptinezumab proved to be effective in preventing episodic and chronic migraine even in patients with 2 to 4 prior preventive failures and in shortening the time to complete migraine freedom when infused during a moderate-to severe migraine attack. Eptinezumab 100 mg can be used for the first administration and later if deemed necessary, the dose upgraded to 300 mg.
EMBRACE is a multicenter, prospective, cohort, real-life study carried out in Italian headache centers. Consecutive patients with high frequency episodic (HFEM: ≥8 migraine days/month) or CM (≥15 headache days/month), according to The International Classification of Headache Disorders, 3rd edition (ICHD-III), referred to participating centers. The aim of this study is to assess effectiveness, safety and tolerability of eptinezumab 100 mg iv or 300 mg iv with a quarterly dosing regimen in a real-world migraine patients population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive patients aged 18-75 affected by hight frequency or chronic migraine with or without medication overuse.
Key inclusion criteria (5 listed)
- Age between 18 and 75 years;
- Males and females;
- Willingness to sign the informed consent;
- High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months;
- Chronic migraine, according to the ICHD-III criteria;
Key exclusion criteria (4 listed)
- Other headaches different than migraine;
- Known intolerance to eptinezumab or eccipients;
- Current treatment with other mAbs;
- Vascular disease or Raynaud.
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 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solutionAlso: anti CGRP monoclonal antibodymigraine prophylaxis | Drug | – |
Primary outcome
Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;
Time frame: over 12 weeks of treatment compared to baseline
assessment of MMD or MHD
Change from baseline in MMD in HFEM or MHD in CM;
Time frame: over 24 weeks of treatment compared to baseline
assessment of MMD or MHD
Change from baseline in MMD in HFEM or MHD in CM;
Time frame: over 48 weeks of treatment compared to baseline
assessment of MMD or MHD
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: over 12 months of treatment compared to baseline
assessment of occurrence of Treatment-Emergent Adverse Events
26 secondary outcomes
Change in monthly analgesic intake
Time frame: over 12 weeks compared to baseline
Change in monthly analgesic intake
Time frame: over 24 weeks compared to baseline
Change in monthly analgesic intake
Time frame: over 48 weeks compared to baseline
Change in Numeric Rating Scale (NRS)
Time frame: over 12 weeks compared to baseline
Change in Numeric Rating Scale (NRS)
Time frame: over 24 weeks compared to baseline
Change in Numeric Rating Scale (NRS)
Time frame: over 48 weeks compared to baseline
Change in Headache Impact Test-6 (HIT-6)
Time frame: over 12 weeks compared to baseline
Change in Headache Impact Test-6 (HIT-6)
Time frame: over 24 weeks compared to baseline
Change in Headache Impact Test-6 (HIT-6)
Time frame: over 48 weeks compared to baseline
Change in Migraine Disability Assessment Score (MIDAS)
Time frame: over 12 weeks compared to baseline
Change in Migraine Disability Assessment Score (MIDAS)
Time frame: over 24 weeks compared to baseline
Change in Migraine Disability Assessment Score (MIDAS)
Time frame: over 48 weeks compared to baseline
Change in Migraine interictal burden (MIBS-4)
Time frame: over 12 weeks compared to baseline
Change in Migraine interictal burden (MIBS-4)
Time frame: over 24 weeks compared to baseline
Change in Migraine interictal burden (MIBS-4)
Time frame: over 48 weeks compared to baseline
Change in Patient Global Impression of change (PGIC) scale
Time frame: over 12 weeks compared to baseline
Change in Patient Global Impression of change (PGIC) scale
Time frame: over 24 weeks compared to baseline
Change in Patient Global Impression of change (PGIC) scale
Time frame: over 48 weeks compared to baseline
≥50%, ≥75% and 100% response rates
Time frame: over 12 weeks compared to baseline
≥50%, ≥75% and 100% response rates
Time frame: over 24 weeks compared to baseline
≥50%, ≥75% and 100% response rates
Time frame: over 48 weeks compared to baseline
Percentage of migraine free patients on the day after dosing (infusion of eptinezumab)
Time frame: the day after infusion of eptinezumab (first infusion of eptinezumab)
Percentage of migraine free patients on the day after dosing (infusion of eptinezumab)
Time frame: the day after infusion of eptinezumab (second infusion of eptinezumab)
Proportion of patients with medication overuse at baseline reverting to no medication overuse
Time frame: over 12 weeks compared to baseline
Proportion of patients with medication overuse at baseline reverting to no medication overuse
Time frame: over 24 weeks compared to baseline
Proportion of patients with medication overuse at baseline reverting to no medication overuse
Time frame: over 48 weeks compared to baseline
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 1 May 2025.
- Background: PubMed 33280422Villar-Martinez MD, Moreno-Ajona D, Goadsby PJ. Eptinezumab for the preventive treatment of migraine. Pain Manag. 2021 Mar;11(2):113-121. doi: 10.2217/pmt-2020-0075. Epub 2020 Dec 7.
- Background: PubMed 32209650Lipton RB, Goadsby PJ, Smith J, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Cady R. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar 31;94(13):e1365-e1377. doi: 10.1212/WNL.0000000000009169. Epub 2020 Mar 24.
- Background: PubMed 35716692Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.
- Results publication: PubMed 32075406Ashina M, Saper J, Cady R, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Smith J. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020 Mar;40(3):241-254. doi: 10.1177/0333102420905132. Epub 2020 Feb 19.
- Derived from this study: PubMed 42262724Barbanti P, Aurilia C, Filippi M, Doretti A, d'Onofrio F, Scatena P, Vecchio R, Messina R, Vinciguerra L, Ranieri A, Baldisseri F, Torelli P, Russo M, Cutrona C, Viticchi G, Egeo G, Autunno M, Pistoia F, Finocchi C, Camarda C, Messina S, Rinalduzzi S, Drago V, Caputi L, Bandettini di Poggio M, Quintana S, Salerno A, Bartolini M, Fiorentini G, Spieckert de Souza J, Di Stani F, Bonassi S, Porreca A; Italian Migraine Registry Study Group. Real-World Response and Super-Response to Eptinezumab over 48 Weeks in Migraine: The Prospective Multicenter EMBRACE III Study. Neurol Ther. 2026 Jun 9. doi: 10.1007/s40120-026-00971-7. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Piero Barbanti, MD, PhD study chair
IRCCS San Raffaele Roma
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 Disorders, run by IRCCS San Raffaele Roma 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 5 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 1 May 2025. 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 Piero Barbanti, MD, PhD (+393357071457, piero.barbanti@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM; (time frame: over 12 weeks of treatment compared to baseline). The study lists 4 primary outcomes in all. 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 NCT05570149, which also lists 5 linked publications.
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 1 May 2025.