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

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

Migraine Disorders

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.

Eptinezumab

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

the change in monthly migraine days at months 3-6-9-12 compared to baseline

adverse events occurred in 12 months of treatment

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

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

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