Real-World Response and Super-Response to Eptinezumab over 48 Weeks in Migraine: The Prospective Multicenter EMBRACE III Study.
Piero Barbanti, Cinzia Aurilia, Massimo Filippi...
https://pubmed.ncbi.nlm.nih.gov/42262724/Actively Recruiting
Led by IRCCS San Raffaele Roma · Updated on 2025-05-01
500
Participants Needed
1
Research Sites
52 weeks
Total Duration
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 patients 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 treatments real-life effects and tolerability.
CONDITIONS
EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.
P
Piero Barbanti, MD, PhD
C
Cinzia Aurilia, MD
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IRCCS San Raffaele Roma
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Lead Sponsor