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NCT Number: NCT05570149

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

The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

KEY INCLUSION CRITERIA

  • 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

  • Other headaches different than migraine;
  • Known intolerance to eptinezumab or eccipients;
  • Current treatment with other mAbs;
  • Vascular disease or Raynaud.

Treatment and study plan

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

Drug

migraine prophylaxis

Other names: anti CGRP monoclonal antibody

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Change in monthly analgesic intake

    Time frame: over 12 weeks compared to baseline

    Assessment of monthly analgesic intake

  2. Change in monthly analgesic intake

    Time frame: over 24 weeks compared to baseline

    Assessment of monthly analgesic intake

  3. Change in monthly analgesic intake

    Time frame: over 48 weeks compared to baseline

    Assessment of monthly analgesic intake

  4. Change in Numeric Rating Scale (NRS)

    Time frame: over 12 weeks compared to baseline

    Assessment of NRS

  5. Change in Numeric Rating Scale (NRS)

    Time frame: over 24 weeks compared to baseline

    Assessment of NRS

  6. Change in Numeric Rating Scale (NRS)

    Time frame: over 48 weeks compared to baseline

    Assessment of NRS

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

    Time frame: over 12 weeks compared to baseline

    Assessment of HIT-6

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

    Time frame: over 24 weeks compared to baseline

    Assessment of HIT-6

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

    Time frame: over 48 weeks compared to baseline

    Assessment of HIT-6

  10. Change in Migraine Disability Assessment Score (MIDAS)

    Time frame: over 12 weeks compared to baseline

    Assessment of MIDAS

  11. Change in Migraine Disability Assessment Score (MIDAS)

    Time frame: over 24 weeks compared to baseline

    Assessment of MIDAS

  12. Change in Migraine Disability Assessment Score (MIDAS)

    Time frame: over 48 weeks compared to baseline

    Assessment of MIDAS

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

    Time frame: over 12 weeks compared to baseline

    Assessment of MIBS-4

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

    Time frame: over 24 weeks compared to baseline

    Assessment of MIBS-4

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

    Time frame: over 48 weeks compared to baseline

    Assessment of MIBS

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

    Time frame: over 12 weeks compared to baseline

    Assessment of MIBS

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

    Time frame: over 24 weeks compared to baseline

    Assessment of MIBS

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

    Time frame: over 48 weeks compared to baseline

    Assessment of MIBS

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

    Time frame: over 12 weeks compared to baseline

    Assessment of responder rates

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

    Time frame: over 24 weeks compared to baseline

    Assessment of responder rates

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

    Time frame: over 48 weeks compared to baseline

    Assessment of responder rates

  22. 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)

    Assessment of percentage of migraine free patients on the day after dosing (first infusion of eptinezumab)

  23. 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)

    Assessment of percentage of migraine free patients on the day after dosing (second infusion of eptinezumab)

  24. Proportion of patients with medication overuse at baseline reverting to no medication overuse

    Time frame: over 12 weeks compared to baseline

    Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse

  25. Proportion of patients with medication overuse at baseline reverting to no medication overuse

    Time frame: over 24 weeks compared to baseline

    Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse

  26. Proportion of patients with medication overuse at baseline reverting to no medication overuse

    Time frame: over 48 weeks compared to baseline

    Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse

Study contacts

Contact information is provided by the study sponsor or research team.

Cinzia Aurilia, MD

CONTACT

[email protected]

+393334147390

Piero Barbanti, MD, PhD

CONTACT

[email protected]

+393357071457

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Official study title

EptinezuMaB in ReAl-world evidenCE: a 12-Months, Multicenter, Real-Life, Cohort Study in High-Frequency Episodic and Chronic Migraine (the EMBRACE Study)

Acronym: EMBRACE

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 6, 2022
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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