Clinical trial NCT05570149: EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.
Official title: EptinezuMaB in ReAl-world evidenCE: a 12-Months, Multicenter, Real-Life, Cohort Study in High-Frequency Episodic and Chronic Migraine (the EMBRACE Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine Disorders
Keywords: Eptinezumab,
Calcitonin gene-related peptide,
Effectiveness,
Real-life,
Migraine,
Safety
Treatment
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all consecutive patients aged 18-75 affected by hight frequency or chronic migraine with or without medication overuse.

Brief summary: The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.

Detailed description: 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.

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.

Primary outcomes:
measure: Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;
timeFrame: over 12 weeks of treatment compared to baseline
measure: Change from baseline in MMD in HFEM or MHD in CM;
timeFrame: over 24 weeks of treatment compared to baseline
measure: Change from baseline in MMD in HFEM or MHD in CM;
timeFrame: over 48 weeks of treatment compared to baseline
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: over 12 months of treatment compared to baseline
Secondary outcomes:
measure: Change in monthly analgesic intake
timeFrame: over 12 weeks compared to baseline
measure: Change in monthly analgesic intake
timeFrame: over 24 weeks compared to baseline
measure: Change in monthly analgesic intake
timeFrame: over 48 weeks compared to baseline
measure: Change in Numeric Rating Scale (NRS)
timeFrame: over 12 weeks compared to baseline
measure: Change in Numeric Rating Scale (NRS)
timeFrame: over 24 weeks compared to baseline
measure: Change in Numeric Rating Scale (NRS)
timeFrame: over 48 weeks compared to baseline
measure: Change in Headache Impact Test-6 (HIT-6)
timeFrame: over 12 weeks compared to baseline
measure: Change in Headache Impact Test-6 (HIT-6)
timeFrame: over 24 weeks compared to baseline
measure: Change in Headache Impact Test-6 (HIT-6)
timeFrame: over 48 weeks compared to baseline
measure: Change in Migraine Disability Assessment Score (MIDAS)
timeFrame: over 12 weeks compared to baseline
measure: Change in Migraine Disability Assessment Score (MIDAS)
timeFrame: over 24 weeks compared to baseline
measure: Change in Migraine Disability Assessment Score (MIDAS)
timeFrame: over 48 weeks compared to baseline
measure: Change in Migraine interictal burden (MIBS-4)
timeFrame: over 12 weeks compared to baseline
measure: Change in Migraine interictal burden (MIBS-4)
timeFrame: over 24 weeks compared to baseline
measure: Change in Migraine interictal burden (MIBS-4)
timeFrame: over 48 weeks compared to baseline
measure: Change in Patient Global Impression of change (PGIC) scale
timeFrame: over 12 weeks compared to baseline
measure: Change in Patient Global Impression of change (PGIC) scale
timeFrame: over 24 weeks compared to baseline
measure: Change in Patient Global Impression of change (PGIC) scale
timeFrame: over 48 weeks compared to baseline
measure: ≥50%, ≥75% and 100% response rates
timeFrame: over 12 weeks compared to baseline
measure: ≥50%, ≥75% and 100% response rates
timeFrame: over 24 weeks compared to baseline
measure: ≥50%, ≥75% and 100% response rates
timeFrame: over 48 weeks compared to baseline
measure: Percentage of migraine free patients on the day after dosing (infusion of eptinezumab)
timeFrame: the day after infusion of eptinezumab (first infusion of eptinezumab)
measure: Percentage of migraine free patients on the day after dosing (infusion of eptinezumab)
timeFrame: the day after infusion of eptinezumab (second infusion of eptinezumab)
measure: Proportion of patients with medication overuse at baseline reverting to no medication overuse
timeFrame: over 12 weeks compared to baseline
measure: Proportion of patients with medication overuse at baseline reverting to no medication overuse
timeFrame: over 24 weeks compared to baseline
measure: Proportion of patients with medication overuse at baseline reverting to no medication overuse
timeFrame: over 48 weeks compared to baseline
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IRCCS San Raffaele Roma
state: RM
Study officials:
affiliation: IRCCS San Raffaele Roma
name: Piero Barbanti, MD, PhD
role: STUDY_CHAIR
References:
citation: Ashina M, Saper J, Cady R, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Smith J. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020 Mar;40(3):241-254. doi: 10.1177/0333102420905132. Epub 2020 Feb 19.
citation: Villar-Martinez MD, Moreno-Ajona D, Goadsby PJ. Eptinezumab for the preventive treatment of migraine. Pain Manag. 2021 Mar;11(2):113-121. doi: 10.2217/pmt-2020-0075. Epub 2020 Dec 7.
citation: Lipton RB, Goadsby PJ, Smith J, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Cady R. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar 31;94(13):e1365-e1377. doi: 10.1212/WNL.0000000000009169. Epub 2020 Mar 24.
citation: Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Safety 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. Lancet Neurol. 2022 Jul;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.