The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.
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.
Study Type
OBSERVATIONAL
Enrollment
500
migraine prophylaxis
IRCCS San Raffaele Roma
Roma, RM, Italy
RECRUITINGChange from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;
assessment of MMD or MHD
Time frame: over 12 weeks of treatment compared to baseline
Change from baseline in MMD in HFEM or MHD in CM;
assessment of MMD or MHD
Time frame: over 24 weeks of treatment compared to baseline
Change from baseline in MMD in HFEM or MHD in CM;
assessment of MMD or MHD
Time frame: over 48 weeks of treatment compared to baseline
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
assessment of occurrence of Treatment-Emergent Adverse Events
Time frame: over 12 months of treatment compared to baseline
Change in monthly analgesic intake
Assessment of monthly analgesic intake
Time frame: over 12 weeks compared to baseline
Change in monthly analgesic intake
Assessment of monthly analgesic intake
Time frame: over 24 weeks compared to baseline
Change in monthly analgesic intake
Assessment of monthly analgesic intake
Time frame: over 48 weeks compared to baseline
Change in Numeric Rating Scale (NRS)
Assessment of NRS
Time frame: over 12 weeks compared to baseline
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Change in Numeric Rating Scale (NRS)
Assessment of NRS
Time frame: over 24 weeks compared to baseline
Change in Numeric Rating Scale (NRS)
Assessment of NRS
Time frame: over 48 weeks compared to baseline
Change in Headache Impact Test-6 (HIT-6)
Assessment of HIT-6
Time frame: over 12 weeks compared to baseline
Change in Headache Impact Test-6 (HIT-6)
Assessment of HIT-6
Time frame: over 24 weeks compared to baseline
Change in Headache Impact Test-6 (HIT-6)
Assessment of HIT-6
Time frame: over 48 weeks compared to baseline
Change in Migraine Disability Assessment Score (MIDAS)
Assessment of MIDAS
Time frame: over 12 weeks compared to baseline
Change in Migraine Disability Assessment Score (MIDAS)
Assessment of MIDAS
Time frame: over 24 weeks compared to baseline
Change in Migraine Disability Assessment Score (MIDAS)
Assessment of MIDAS
Time frame: over 48 weeks compared to baseline
Change in Migraine interictal burden (MIBS-4)
Assessment of MIBS-4
Time frame: over 12 weeks compared to baseline
Change in Migraine interictal burden (MIBS-4)
Assessment of MIBS-4
Time frame: over 24 weeks compared to baseline
Change in Migraine interictal burden (MIBS-4)
Assessment of MIBS
Time frame: over 48 weeks compared to baseline
Change in Patient Global Impression of change (PGIC) scale
Assessment of MIBS
Time frame: over 12 weeks compared to baseline
Change in Patient Global Impression of change (PGIC) scale
Assessment of MIBS
Time frame: over 24 weeks compared to baseline
Change in Patient Global Impression of change (PGIC) scale
Assessment of MIBS
Time frame: over 48 weeks compared to baseline
≥50%, ≥75% and 100% response rates
Assessment of responder rates
Time frame: over 12 weeks compared to baseline
≥50%, ≥75% and 100% response rates
Assessment of responder rates
Time frame: over 24 weeks compared to baseline
≥50%, ≥75% and 100% response rates
Assessment of responder rates
Time frame: over 48 weeks compared to baseline
Percentage of migraine free patients on the day after dosing (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 (first infusion of eptinezumab)
Percentage of migraine free patients on the day after dosing (infusion of eptinezumab)
Assessment of percentage of migraine free patients on the day after dosing (second infusion of eptinezumab)
Time frame: the day after infusion of eptinezumab (second infusion of eptinezumab)
Proportion of patients with medication overuse at baseline reverting to no medication overuse
Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse
Time frame: over 12 weeks compared to baseline
Proportion of patients with medication overuse at baseline reverting to no medication overuse
Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse
Time frame: over 24 weeks compared to baseline
Proportion of patients with medication overuse at baseline reverting to no medication overuse
Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse
Time frame: over 48 weeks compared to baseline