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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution | Drug | migraine prophylaxis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM; | assessment of MMD or MHD | over 12 weeks of treatment compared to baseline |
| Change from baseline in MMD in HFEM or MHD in CM; | assessment of MMD or MHD | over 24 weeks of treatment compared to baseline |
| Change from baseline in MMD in HFEM or MHD in CM; | assessment of MMD or MHD | 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 | over 12 months of treatment compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in monthly analgesic intake | Assessment of monthly analgesic intake | over 12 weeks compared to baseline |
| Change in monthly analgesic intake | Assessment of monthly analgesic intake |
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KEY INCLUSION CRITERIA
KEY EXCLUSION CRITERIA
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all consecutive patients aged 18-75 affected by hight frequency or chronic migraine with or without medication overuse.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piero Barbanti, MD, PhD | Contact | +393357071457 | piero.barbanti@sanraffaele.it | |
| Cinzia Aurilia, MD | Contact | +393334147390 | cinzia.aurilia@sanraffaele.it |
| Name | Affiliation | Role |
|---|---|---|
| Piero Barbanti, MD, PhD | IRCCS San Raffaele Roma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Roma | Recruiting | Roma | RM | 00163 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33280422 | Background | 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. | |
| 32209650 | Background | 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. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000628361 | eptinezumab |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| over 24 weeks compared to baseline |
| Change in monthly analgesic intake | Assessment of monthly analgesic intake | over 48 weeks compared to baseline |
| Change in Numeric Rating Scale (NRS) | Assessment of NRS | over 12 weeks compared to baseline |
| Change in Numeric Rating Scale (NRS) | Assessment of NRS | over 24 weeks compared to baseline |
| Change in Numeric Rating Scale (NRS) | Assessment of NRS | over 48 weeks compared to baseline |
| Change in Headache Impact Test-6 (HIT-6) | Assessment of HIT-6 | over 12 weeks compared to baseline |
| Change in Headache Impact Test-6 (HIT-6) | Assessment of HIT-6 | over 24 weeks compared to baseline |
| Change in Headache Impact Test-6 (HIT-6) | Assessment of HIT-6 | over 48 weeks compared to baseline |
| Change in Migraine Disability Assessment Score (MIDAS) | Assessment of MIDAS | over 12 weeks compared to baseline |
| Change in Migraine Disability Assessment Score (MIDAS) | Assessment of MIDAS | over 24 weeks compared to baseline |
| Change in Migraine Disability Assessment Score (MIDAS) | Assessment of MIDAS | over 48 weeks compared to baseline |
| Change in Migraine interictal burden (MIBS-4) | Assessment of MIBS-4 | over 12 weeks compared to baseline |
| Change in Migraine interictal burden (MIBS-4) | Assessment of MIBS-4 | over 24 weeks compared to baseline |
| Change in Migraine interictal burden (MIBS-4) | Assessment of MIBS | over 48 weeks compared to baseline |
| Change in Patient Global Impression of change (PGIC) scale | Assessment of MIBS | over 12 weeks compared to baseline |
| Change in Patient Global Impression of change (PGIC) scale | Assessment of MIBS | over 24 weeks compared to baseline |
| Change in Patient Global Impression of change (PGIC) scale | Assessment of MIBS | over 48 weeks compared to baseline |
| ≥50%, ≥75% and 100% response rates | Assessment of responder rates | over 12 weeks compared to baseline |
| ≥50%, ≥75% and 100% response rates | Assessment of responder rates | over 24 weeks compared to baseline |
| ≥50%, ≥75% and 100% response rates | Assessment of responder rates | 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) | 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) | 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 | 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 | 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 | over 48 weeks compared to baseline |
| 35716692 | Background | 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. |
| 32075406 | Result | 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. |
| 42262724 | Derived | 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; Italian Migraine Registry Study Group. Real-World Response and Super-Response to Eptinezumab over 48 Weeks in Migraine: The Prospective Multicenter EMBRACE III Study. Neurol Ther. 2026 Jun 9. doi: 10.1007/s40120-026-00971-7. Online ahead of print. |
| D009422 | Nervous System Diseases |