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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-12-31

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.

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Detailed Description

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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.

Conditions

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Migraine Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution

migraine prophylaxis

Intervention Type DRUG

Other Intervention Names

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anti CGRP monoclonal antibody

Eligibility Criteria

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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;

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No