EMBRACE: EptinezuMaB in ReAl-world evidenCE: a 12 Week, Multicenter, Real Life, Cohort Study in Migraine.

Sponsor

IRCCS San Raffaele Roma (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05570149

Collaborator

(none)

500

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Migraine Disorders	Drug: Eptinezumab

Detailed Description

Eptinezumab is a fully human Ig-2 monoclonal antibody blocking the calcitonin gene-related peptide, indicated for migraine prophylaxis. Phase II and III trials demonstrated that eptinezumab is effective, safe, and well tolerated in the preventionof episodic and chronic migraine, showing an early onset of action.

EMBRACE is a multicenter, prospective, cohort, real-life study carried out in Italian headache centers. We will consider for enrolment all consecutive patients aged 18-65 affected by high frequency episodic migraine or chronic migraine with or without medication overuse,according to the criteria of the International Classification of Headache Disorders, 3rd edition.

Each patient will be treated with eptinezumab 100 mg administered intravenously every 3 months.The following effectiveness variables will be analyzed:

change from baseline in the overall number of monthly migraine days/monthly headache days;
responder rates (≥50%, ≥75%, and 100% reduction from baseline in the number of monthly migraine days/monthly headache days;
change from baseline in the overall number (counts) of acute migraine medications per month;
change from baseline in, MIDAS, VAS and HIT-6 scores.

Treatment duration will be planned to last from 6 to 12 months, depending on the patient's response, in keeping with the suggestions of the European Headache Federation guidelines. We will consider non responders migraine patients who did not reach a 50% reduction in monthly migraine days for patients with high frequency episodic migraine or in monthly headache days, for patients with chronic migraine, compared to baseline.

The safety analysis set included all patients who received at least one dose of eptinezumab.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2026

Outcome Measures

Primary Outcome Measures

effectiveness of eptinezumab at months 3-6-9-12 compared to baseline. [from baseline to months 12]
the change in monthly migraine days at months 3-6-9-12 compared to baseline

Secondary Outcome Measures

safety of eptinezumab in real life study [from baseline to months 12]
adverse events occurred in 12 months of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: all consecutive patients aged 18-75 affected by high-frequency episodic migraine or chronic migraine, with or without medication overuse. -

Exclusion Criteria: patients affected by other headaches or who have been treated with other anti-CGRP monoclonal antibodies.