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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Piero Barbanti, MD, PhD; Phone Number: +393357071457; Email: piero.barbanti@sanraffaele.it
• Study Contact Backup: Name: Cinzia Aurilia, MD; Phone Number: +393334147390; Email: cinzia.aurilia@sanraffaele.it

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00163
      • Recruiting
      • IRCCS San Raffaele Roma
      • Contact: Piero Barbanti, MD, PhD; Phone Number: 0652254026; Email: piero.barbanti@sanraffaele.it
      • Contact: Cinzia Aurilia, MD; Phone Number: 0652254026; Email: cinzia.aurilia@sanraffaele.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;	assessment of MMD or MHD	over 12 weeks of treatment compared to baseline
Change from baseline in MMD in HFEM or MHD in CM;	assessment of MMD or MHD	over 24 weeks of treatment compared to baseline
Change from baseline in MMD in HFEM or MHD in CM;	assessment of MMD or MHD	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	over 12 months of treatment compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in monthly analgesic intake	Assessment of monthly analgesic intake	over 12 weeks compared to baseline
Change in monthly analgesic intake	Assessment of monthly analgesic intake	over 24 weeks compared to baseline
Change in monthly analgesic intake	Assessment of monthly analgesic intake	over 48 weeks compared to baseline
Change in Numeric Rating Scale (NRS)	Assessment of NRS	over 12 weeks compared to baseline
Change in Numeric Rating Scale (NRS)	Assessment of NRS	over 24 weeks compared to baseline
Change in Numeric Rating Scale (NRS)	Assessment of NRS	over 48 weeks compared to baseline
Change in Headache Impact Test-6 (HIT-6)	Assessment of HIT-6	over 12 weeks compared to baseline
Change in Headache Impact Test-6 (HIT-6)	Assessment of HIT-6	over 24 weeks compared to baseline
Change in Headache Impact Test-6 (HIT-6)	Assessment of HIT-6	over 48 weeks compared to baseline
Change in Migraine Disability Assessment Score (MIDAS)	Assessment of MIDAS	over 12 weeks compared to baseline
Change in Migraine Disability Assessment Score (MIDAS)	Assessment of MIDAS	over 24 weeks compared to baseline
Change in Migraine Disability Assessment Score (MIDAS)	Assessment of MIDAS	over 48 weeks compared to baseline
Change in Migraine interictal burden (MIBS-4)	Assessment of MIBS-4	over 12 weeks compared to baseline
Change in Migraine interictal burden (MIBS-4)	Assessment of MIBS-4	over 24 weeks compared to baseline
Change in Migraine interictal burden (MIBS-4)	Assessment of MIBS	over 48 weeks compared to baseline
Change in Patient Global Impression of change (PGIC) scale	Assessment of MIBS	over 12 weeks compared to baseline
Change in Patient Global Impression of change (PGIC) scale	Assessment of MIBS	over 24 weeks compared to baseline
Change in Patient Global Impression of change (PGIC) scale	Assessment of MIBS	over 48 weeks compared to baseline
≥50%, ≥75% and 100% response rates	Assessment of responder rates	over 12 weeks compared to baseline
≥50%, ≥75% and 100% response rates	Assessment of responder rates	over 24 weeks compared to baseline
≥50%, ≥75% and 100% response rates	Assessment of responder rates	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)	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)	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	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	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	over 48 weeks compared to baseline

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma
• Investigators: Study Chair: Piero Barbanti, MD, PhD, IRCCS San Raffaele Roma

Publications and helpful links

General 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.
• 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.
• 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.
• 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. Erratum In: Neurology. 2023 Aug 8;101(6):283. doi: 10.1212/WNL.0000000000207168.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Treatment; Safety; Migraine,; Eptinezumab,; Calcitonin gene-related peptide,; Effectiveness,; Real-life,
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Immunologic Factors; Physiological Effects of Drugs; Antibodies, Monoclonal
• Other Study ID Numbers: RP 177/SR/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No