IRCCS San Raffaele Roma
Roma, RM, 00163, Italy
Location status: Recruiting
Location contact
Cinzia Aurilia, MD
CONTACT
Piero Barbanti, MD, PhD
CONTACT
NCT Number: NCT05570149
The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Roma, RM, 00163, Italy
Location status: Recruiting
Cinzia Aurilia, MD
CONTACT
Piero Barbanti, MD, PhD
CONTACT
Eptinezumab is an humanized IgG1 and the only antiCGRP mAb administered intravenously by a quarterly dosing regimen. In randomized-controlled studies (RCTs), eptinezumab proved to be effective in preventing episodic and chronic migraine even in patients with 2 to 4 prior preventive failures and in shortening the time to complete migraine freedom when infused during a moderate-to severe migraine attack. Eptinezumab 100 mg can be used for the first administration and later if deemed necessary, the dose upgraded to 300 mg.
EMBRACE is a multicenter, prospective, cohort, real-life study carried out in Italian headache centers. Consecutive patients with high frequency episodic (HFEM: ≥8 migraine days/month) or CM (≥15 headache days/month), according to The International Classification of Headache Disorders, 3rd edition (ICHD-III), referred to participating centers. The aim of this study is to assess effectiveness, safety and tolerability of eptinezumab 100 mg iv or 300 mg iv with a quarterly dosing regimen in a real-world migraine patients population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
KEY INCLUSION CRITERIA
KEY EXCLUSION CRITERIA
migraine prophylaxis
Other names: anti CGRP monoclonal antibody
Time frame: over 12 weeks of treatment compared to baseline
assessment of MMD or MHD
Time frame: over 24 weeks of treatment compared to baseline
assessment of MMD or MHD
Time frame: over 48 weeks of treatment compared to baseline
assessment of MMD or MHD
Time frame: over 12 months of treatment compared to baseline
assessment of occurrence of Treatment-Emergent Adverse Events
Time frame: over 12 weeks compared to baseline
Assessment of monthly analgesic intake
Time frame: over 24 weeks compared to baseline
Assessment of monthly analgesic intake
Time frame: over 48 weeks compared to baseline
Assessment of monthly analgesic intake
Time frame: over 12 weeks compared to baseline
Assessment of NRS
Time frame: over 24 weeks compared to baseline
Assessment of NRS
Time frame: over 48 weeks compared to baseline
Assessment of NRS
Time frame: over 12 weeks compared to baseline
Assessment of HIT-6
Time frame: over 24 weeks compared to baseline
Assessment of HIT-6
Time frame: over 48 weeks compared to baseline
Assessment of HIT-6
Time frame: over 12 weeks compared to baseline
Assessment of MIDAS
Time frame: over 24 weeks compared to baseline
Assessment of MIDAS
Time frame: over 48 weeks compared to baseline
Assessment of MIDAS
Time frame: over 12 weeks compared to baseline
Assessment of MIBS-4
Time frame: over 24 weeks compared to baseline
Assessment of MIBS-4
Time frame: over 48 weeks compared to baseline
Assessment of MIBS
Time frame: over 12 weeks compared to baseline
Assessment of MIBS
Time frame: over 24 weeks compared to baseline
Assessment of MIBS
Time frame: over 48 weeks compared to baseline
Assessment of MIBS
Time frame: over 12 weeks compared to baseline
Assessment of responder rates
Time frame: over 24 weeks compared to baseline
Assessment of responder rates
Time frame: over 48 weeks compared to baseline
Assessment of responder rates
Time frame: the day after infusion of eptinezumab (first infusion of eptinezumab)
Assessment of percentage of migraine free patients on the day after dosing (first infusion of eptinezumab)
Time frame: the day after infusion of eptinezumab (second infusion of eptinezumab)
Assessment of percentage of migraine free patients on the day after dosing (second infusion of eptinezumab)
Time frame: over 12 weeks compared to baseline
Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse
Time frame: over 24 weeks compared to baseline
Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse
Time frame: over 48 weeks compared to baseline
Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse
Contact information is provided by the study sponsor or research team.
Cinzia Aurilia, MD
CONTACT
Piero Barbanti, MD, PhD
CONTACT
IRCCS San Raffaele Roma
Other
EptinezuMaB in ReAl-world evidenCE: a 12-Months, Multicenter, Real-Life, Cohort Study in High-Frequency Episodic and Chronic Migraine (the EMBRACE Study)
Acronym: EMBRACE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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