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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Drugs / interventions | eptinezumab |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | May 1, 2025 |
| Trial ID | NCT05570149 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
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IRCCS San Raffaele Roma
Roma, Rm, Italy Recruiting
Study contacts
- Study coordinator: Piero Barbanti, MD, PhD
- Email: piero.barbanti@sanraffaele.it
- Phone: +393357071457
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.