Assessing the effectiveness of eptinezumab for migraine treatment in real-world settings
EptinezuMaB in ReAl-world evidenCE: a 12-Months, Multicenter, Real-Life, Cohort Study in High-Frequency Episodic and Chronic Migraine (the EMBRACE Study)
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Drugs / interventions | eptinezumab |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT05570149 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with high frequency episodic migraine or chronic migraine as defined by international criteria.
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.
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 performed: Previous randomized-controlled studies have shown eptinezumab to be effective, suggesting potential success for this real-world observational approach.
Eligibility criteria
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 this trial is running
Roma, RM
- IRCCS San Raffaele Roma — Roma, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Piero Barbanti, MD, PhD
- Email: piero.barbanti@sanraffaele.it
- Phone: +393357071457
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.