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RecruitingNCT05570149EMBRACEUpdated May 1, 2025

EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.

An observational study in Migraine Disorders, sponsored by IRCCS San Raffaele Roma. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-01.

Sponsored by IRCCS San Raffaele Roma · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Migraine Disorders

Browse trials for

Keywords

  • Eptinezumab,
  • Calcitonin gene-related peptide,
  • Effectiveness,
  • Real-life,
  • Migraine,
  • Safety
  • Treatment
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's planned enrollment of 500 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

IRCCS San Raffaele Roma is the lead sponsor of 63 studies on the registry; 28 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

all consecutive patients aged 18-75 affected by hight frequency or chronic migraine with or without medication overuse.

Eligibility criteria

KEY INCLUSION CRITERIA

  1. Age between 18 and 75 years;
  2. Males and females;
  3. Willingness to sign the informed consent;
  4. High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months;
  5. Chronic migraine, according to the ICHD-III criteria;

KEY EXCLUSION CRITERIA

  1. Other headaches different than migraine;
  2. Known intolerance to eptinezumab or eccipients;
  3. Current treatment with other mAbs;
  4. Vascular disease or Raynaud.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Interventions

  • DrugEptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution

    migraine prophylaxis

    Also known as: anti CGRP monoclonal antibody

06

What researchers measure

Primary outcomes

  1. Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;

    assessment of MMD or MHD

    Time frame: over 12 weeks of treatment compared to baseline

  2. Change from baseline in MMD in HFEM or MHD in CM;

    assessment of MMD or MHD

    Time frame: over 24 weeks of treatment compared to baseline

  3. Change from baseline in MMD in HFEM or MHD in CM;

    assessment of MMD or MHD

    Time frame: over 48 weeks of treatment compared to baseline

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    assessment of occurrence of Treatment-Emergent Adverse Events

    Time frame: over 12 months of treatment compared to baseline

Secondary outcomes

  1. Change in monthly analgesic intake

    Assessment of monthly analgesic intake

    Time frame: over 12 weeks compared to baseline

  2. Change in monthly analgesic intake

    Assessment of monthly analgesic intake

    Time frame: over 24 weeks compared to baseline

  3. Change in monthly analgesic intake

    Assessment of monthly analgesic intake

    Time frame: over 48 weeks compared to baseline

  4. Change in Numeric Rating Scale (NRS)

    Assessment of NRS

    Time frame: over 12 weeks compared to baseline

  5. Change in Numeric Rating Scale (NRS)

    Assessment of NRS

    Time frame: over 24 weeks compared to baseline

  6. Change in Numeric Rating Scale (NRS)

    Assessment of NRS

    Time frame: over 48 weeks compared to baseline

  7. Change in Headache Impact Test-6 (HIT-6)

    Assessment of HIT-6

    Time frame: over 12 weeks compared to baseline

  8. Change in Headache Impact Test-6 (HIT-6)

    Assessment of HIT-6

    Time frame: over 24 weeks compared to baseline

  9. Change in Headache Impact Test-6 (HIT-6)

    Assessment of HIT-6

    Time frame: over 48 weeks compared to baseline

  10. Change in Migraine Disability Assessment Score (MIDAS)

    Assessment of MIDAS

    Time frame: over 12 weeks compared to baseline

  11. Change in Migraine Disability Assessment Score (MIDAS)

    Assessment of MIDAS

    Time frame: over 24 weeks compared to baseline

  12. Change in Migraine Disability Assessment Score (MIDAS)

    Assessment of MIDAS

    Time frame: over 48 weeks compared to baseline

  13. Change in Migraine interictal burden (MIBS-4)

    Assessment of MIBS-4

    Time frame: over 12 weeks compared to baseline

  14. Change in Migraine interictal burden (MIBS-4)

    Assessment of MIBS-4

    Time frame: over 24 weeks compared to baseline

  15. Change in Migraine interictal burden (MIBS-4)

    Assessment of MIBS

    Time frame: over 48 weeks compared to baseline

  16. Change in Patient Global Impression of change (PGIC) scale

    Assessment of MIBS

    Time frame: over 12 weeks compared to baseline

  17. Change in Patient Global Impression of change (PGIC) scale

    Assessment of MIBS

    Time frame: over 24 weeks compared to baseline

  18. Change in Patient Global Impression of change (PGIC) scale

    Assessment of MIBS

    Time frame: over 48 weeks compared to baseline

  19. ≥50%, ≥75% and 100% response rates

    Assessment of responder rates

    Time frame: over 12 weeks compared to baseline

  20. ≥50%, ≥75% and 100% response rates

    Assessment of responder rates

    Time frame: over 24 weeks compared to baseline

  21. ≥50%, ≥75% and 100% response rates

    Assessment of responder rates

    Time frame: over 48 weeks compared to baseline

  22. 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)

    Time frame: the day after infusion of eptinezumab (first infusion of eptinezumab)

  23. 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)

    Time frame: the day after infusion of eptinezumab (second infusion of eptinezumab)

  24. 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

    Time frame: over 12 weeks compared to baseline

  25. 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

    Time frame: over 24 weeks compared to baseline

  26. 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

    Time frame: over 48 weeks compared to baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Ashina 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 32075406 ↗
  • 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 33280422 ↗
  • Lipton 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 32209650 ↗
  • Ashina 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 35716692 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05570149
Lead sponsor
IRCCS San Raffaele Roma
Responsible party
Sponsor
First posted
Oct 6, 2022
Start date
Jan 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 1, 2025

Study contacts

Piero Barbanti, MD, PhD
Contact
piero.barbanti@sanraffaele.it
+393357071457
Cinzia Aurilia, MD
Contact
cinzia.aurilia@sanraffaele.it
+393334147390
Piero Barbanti, MD, PhD
study chair · IRCCS San Raffaele Roma

Oversight

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

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