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Clinical trial

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

ID
Name
IRCCS San Raffaele Roma
Description
The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.
Trial arms
Trial start
2023-01-01
Estimated PCD
2024-12-01
Trial end
2026-12-01
Status
Recruiting
Treatment
Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution
migraine prophylaxis
Other names:
anti CGRP monoclonal antibody
Size
500
Primary endpoint
Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;
over 12 weeks of treatment compared to baseline
Change from baseline in MMD in HFEM or MHD in CM;
over 24 weeks of treatment compared to baseline
Change from baseline in MMD in HFEM or MHD in CM;
over 48 weeks of treatment compared to baseline
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
over 12 months of treatment compared to baseline
Eligibility 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '3 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}
Updated at
2024-04-09

1 organization

1 product

1 indication

Organization
IRCCS San Raffaele
Product
Eptinezumab
Indication
Migraine Disorders