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

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

Detailed Description
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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.

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

Conditions
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Migraine Disorders

Intervention / Treatment
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* Drug: Eptinezumab


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Eptinezumab|migraine prophylaxis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness of eptinezumab at months 3-6-9-12 compared to baseline. | the change in monthly migraine days at months 3-6-9-12 compared to baseline | from baseline to months 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of eptinezumab in real life study | adverse events occurred in 12 months of treatment | from baseline to months 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eptinezumab,, Calcitonin gene-related peptide,, Effectiveness,, Real-life,, Migraine,, Safety, Treatment