Eptinezumab for the preventive treatment of migraine.
María Dolores Villar-Martínez, David Moreno-Ajona, Peter J Goadsby
https://pubmed.ncbi.nlm.nih.gov/33280422Actively Recruiting
Age: 18Years - 75Years
All Genders
ID05570149
EptinezuMaB in ReAl-world evidenCE: a 12-Months, Multicenter, Real-Life, Cohort Study in High-Frequency Episodic and Chronic Migraine (the EMBRACE Study)
Led by IRCCS San Raffaele Roma · Updated on 2025-05-01
500
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, and tolerability of eptinezumab in people with high frequency episodic and chronic migraine. This real-world, multicenter study involves patients who experience frequent disabling migraines or chronic headaches, aiming to observe how eptinezumab works outside of controlled clinical trials. The study administers eptinezumab intravenously every three months at doses of either 100 mg or 300 mg, depending on the patient's needs. This treatment is given in Italian headache centers over a 12-month period. Patients receive the medication quarterly, and the dose may be increased after the first infusion if necessary. Participants will be monitored for changes in the number of migraine or headache days over 12, 24, and 48 weeks compared to their baseline. Researchers will also track safety by recording any side effects during the year-long treatment. Additional assessments include changes in pain medication use, headache impact, migraine disability, pain intensity, and patient global impression of change. This comprehensive monitoring helps understand the treatment's real-life effects and tolerability.
CONDITIONS
Brief Title
EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Male or female
- Willing to sign informed consent
- High frequency episodic migraine with at least 8 disabling migraine days per month in the past 3 months
- Diagnosis of chronic migraine according to ICHD-III criteria
You will not qualify if you...
- Having headaches other than migraine
- Known intolerance to eptinezumab or its ingredients
- Currently receiving treatment with other monoclonal antibodies
- Presence of vascular disease or Raynaud syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive eptinezumab intravenously every 12 weeks to prevent high-frequency episodic or chronic migraine.
Quarterly visits for infusions (4 visits) and additional assessments
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele Roma
Roma, RM, Italy, 00163
Actively Recruiting
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Research Team
P
Piero Barbanti, MD, PhD
C
Cinzia Aurilia, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2.
Richard B Lipton, Peter J Goadsby, Jeff Smith...
https://pubmed.ncbi.nlm.nih.gov/32209650Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial.
Messoud Ashina, Michel Lanteri-Minet, Patricia Pozo-Rosich...
https://pubmed.ncbi.nlm.nih.gov/35716692Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1).
Messoud Ashina, Joel Saper, Roger Cady...
https://pubmed.ncbi.nlm.nih.gov/32075406