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

Recruiting

• Conditions: Migraine Disorders

• Registration Number: NCT05570149
• Lead Sponsor: IRCCS San Raffaele Roma

Brief Summary

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 Timeline

• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-06
• Study Start: 2023-01-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;	over 12 weeks of treatment compared to baseline	assessment of MMD or MHD
Change from baseline in MMD in HFEM or MHD in CM;	over 48 weeks of treatment compared to baseline	assessment of MMD or MHD
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	over 12 months of treatment compared to baseline	assessment of occurrence of Treatment-Emergent Adverse Events

Secondary Outcome Measures

Name	Time	Method
Change in monthly analgesic intake	over 48 weeks compared to baseline	Assessment of monthly analgesic intake
Change in Numeric Rating Scale (NRS)	over 48 weeks compared to baseline	Assessment of NRS
Change in Headache Impact Test-6 (HIT-6)	over 48 weeks compared to baseline	Assessment of HIT-6
Change in Migraine Disability Assessment Score (MIDAS)	over 48 weeks compared to baseline	Assessment of MIDAS
Change in Migraine interictal burden (MIBS-4)	over 48 weeks compared to baseline	Assessment of MIBS
Change in Patient Global Impression of change (PGIC) scale	over 48 weeks compared to baseline	Assessment of MIBS
≥50%, ≥75% and 100% response rates	over 48 weeks compared to baseline	Assessment of responder rates
Percentage of migraine free patients on the day after dosing (infusion of eptinezumab)	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)
Proportion of patients with medication overuse at baseline reverting to no medication overuse	over 48 weeks compared to baseline	Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse

Trial Locations

Locations (1)

IRCCS San Raffaele Roma; 🇮🇹 Roma, RM, Italy