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Clinical Trial Summary

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05570149
Study type Observational [Patient Registry]
Source IRCCS San Raffaele Roma
Contact Piero Barbanti, MD, PhD
Phone +393357071457
Email piero.barbanti@sanraffaele.it
Status Recruiting
Phase
Start date January 1, 2023
Completion date December 2026

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