Clinical trial Recruiting at 1 site Observational Ages 18 to 75

Assessing the effectiveness of eptinezumab for migraine treatment in real-world settings

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

Run by IRCCS San Raffaele Roma · NCT05570149 · Data updated 2026-11-12

This study is testing how well eptinezumab, an IV treatment for migraines, works in real life for people who have frequent migraines and haven't had success with other treatments.

More Migraine Disorders trials

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment500 (estimated)
SponsorIRCCS San Raffaele Roma
Academic / other
Drugs / interventionseptinezumab
Locations1 site (Roma, RM)
StatusRecruiting
StartedJanuary 1, 2023
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedMay 1, 2025
Trial IDNCT05570149 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 75 with high frequency episodic migraine or chronic migraine as defined by international criteria.

Probably not a fit

Patients with other types of headaches, known intolerance to eptinezumab, or those currently receiving other monoclonal antibody treatments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the effectiveness, safety, and tolerability of eptinezumab, an intravenous treatment for migraine, in a real-life population. It targets patients with high frequency episodic migraine or chronic migraine, assessing outcomes in those who have previously failed other preventive treatments. The study involves administering eptinezumab at doses of 100 mg or 300 mg quarterly, with data collected from multiple headache centers in Italy to provide insights into its real-world application.

Why it matters

Potential benefit: If successful, this study could provide valuable evidence for the effectiveness of eptinezumab in managing migraine disorders in everyday clinical practice.

How similar studies have gone: Previous randomized-controlled studies have shown eptinezumab to be effective, suggesting potential success for this real-world observational approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
KEY 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;

KEY 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.

Where it's running

  • IRCCS San Raffaele Roma
    Roma, Rm, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.