Menu
Recruiting NCT05570149

EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.

— Observational Migraine Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution.
Who it may be relevant to
Registry conditions: Migraine Disorders. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • Drug Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution
    migraine prophylaxis

Primary outcome measures

  • Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM; [Time frame: over 12 weeks of treatment compared to baseline]
  • Change from baseline in MMD in HFEM or MHD in CM; [Time frame: over 24 weeks of treatment compared to baseline]
  • Change from baseline in MMD in HFEM or MHD in CM; [Time frame: over 48 weeks of treatment compared to baseline]
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: over 12 months of treatment compared to baseline]
Secondary outcome measures (12)
  • Change in monthly analgesic intake [Time frame: over 12 weeks compared to baseline]
  • Change in monthly analgesic intake [Time frame: over 24 weeks compared to baseline]
  • Change in monthly analgesic intake [Time frame: over 48 weeks compared to baseline]
  • Change in Numeric Rating Scale (NRS) [Time frame: over 12 weeks compared to baseline]
  • Change in Numeric Rating Scale (NRS) [Time frame: over 24 weeks compared to baseline]
  • Change in Numeric Rating Scale (NRS) [Time frame: over 48 weeks compared to baseline]
  • Change in Headache Impact Test-6 (HIT-6) [Time frame: over 12 weeks compared to baseline]
  • Change in Headache Impact Test-6 (HIT-6) [Time frame: over 24 weeks compared to baseline]
  • Change in Headache Impact Test-6 (HIT-6) [Time frame: over 48 weeks compared to baseline]
  • Change in Migraine Disability Assessment Score (MIDAS) [Time frame: over 12 weeks compared to baseline]
  • Change in Migraine Disability Assessment Score (MIDAS) [Time frame: over 24 weeks compared to baseline]
  • Change in Migraine Disability Assessment Score (MIDAS) [Time frame: over 48 weeks compared to baseline]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 75 years;
  • Males and females;
  • Willingness to sign the informed consent;
  • High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months;
  • Chronic migraine, according to the ICHD-III criteria;

Exclusion criteria

  • Other headaches different than migraine;
  • Known intolerance to eptinezumab or eccipients;
  • Current treatment with other mAbs;
  • Vascular disease or Raynaud.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS San Raffaele Roma — Roma

Publications

  • 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. PMID 33280422
  • 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. PMID 32209650
  • 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. PMID 35716692
  • 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. PMID 32075406
  • Barbanti P, Aurilia C, Filippi M, Doretti A, d'Onofrio F, Scatena P, Vecchio R, Messina R, Vinciguerra L, Ranieri A, Baldisseri F, Torelli P, Russo M, Cutrona C, Viticchi G, Egeo G, Autunno M, Pistoia F, Finocchi C, Camarda C, Messina S, Rinalduzzi S, Drago V, Caputi L, Bandettini di Poggio M, Quintana S, Salerno A, Bartolini M, Fiorentini G, Spieckert de Souza J, Di Stani F, Bonassi S, Porreca A; PMID 42262724

Identifiers

NCT: NCT05570149 · RP 177/SR/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗