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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM; [Срок оценки: over 12 weeks of treatment compared to baseline]
• Change from baseline in MMD in HFEM or MHD in CM; [Срок оценки: over 24 weeks of treatment compared to baseline]
• Change from baseline in MMD in HFEM or MHD in CM; [Срок оценки: over 48 weeks of treatment compared to baseline]
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: over 12 months of treatment compared to baseline]

Вторичные конечные точки (12)

• Change in monthly analgesic intake [Срок оценки: over 12 weeks compared to baseline]
• Change in monthly analgesic intake [Срок оценки: over 24 weeks compared to baseline]
• Change in monthly analgesic intake [Срок оценки: over 48 weeks compared to baseline]
• Change in Numeric Rating Scale (NRS) [Срок оценки: over 12 weeks compared to baseline]
• Change in Numeric Rating Scale (NRS) [Срок оценки: over 24 weeks compared to baseline]
• Change in Numeric Rating Scale (NRS) [Срок оценки: over 48 weeks compared to baseline]
• Change in Headache Impact Test-6 (HIT-6) [Срок оценки: over 12 weeks compared to baseline]
• Change in Headache Impact Test-6 (HIT-6) [Срок оценки: over 24 weeks compared to baseline]
• Change in Headache Impact Test-6 (HIT-6) [Срок оценки: over 48 weeks compared to baseline]
• Change in Migraine Disability Assessment Score (MIDAS) [Срок оценки: over 12 weeks compared to baseline]
• Change in Migraine Disability Assessment Score (MIDAS) [Срок оценки: over 24 weeks compared to baseline]
• Change in Migraine Disability Assessment Score (MIDAS) [Срок оценки: over 48 weeks compared to baseline]

Критерии участия

Критерии включения

• 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;

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• IRCCS San Raffaele Roma — Roma

Публикации

• 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

Идентификаторы

NCT: NCT05570149 · RP 177/SR/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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