DRUG
Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution
migraine prophylaxis
EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.
Status
Recruiting
Phase
Not applicable
Enrollment
500
Locations
1
Results
Not posted
Publications
5
Study summary
What the protocol is testing.
The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.
Full 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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 6, 2022
Study start
Jan 1, 2023
Primary completion
Dec 31, 2025
Study completion
Dec 31, 2026
Results posted
Not reported
Registry updated
May 1, 2025
Outcomes
What the study measures.
Primary outcomes
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
assessment of MMD or MHD
Change from baseline in MMD in HFEM or MHD in CM;
Time frame · over 24 weeks of treatment compared to baseline
assessment of MMD or MHD
Change from baseline in MMD in HFEM or MHD in CM;
Time frame · over 48 weeks of treatment compared to baseline
assessment of MMD or MHD
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame · over 12 months of treatment compared to baseline
assessment of occurrence of Treatment-Emergent Adverse Events
Secondary outcomes
Change in monthly analgesic intake
Time frame · over 12 weeks compared to baseline
Assessment of monthly analgesic intake
Change in monthly analgesic intake
Time frame · over 24 weeks compared to baseline
Assessment of monthly analgesic intake
Change in monthly analgesic intake
Time frame · over 48 weeks compared to baseline
Assessment of monthly analgesic intake
Change in Numeric Rating Scale (NRS)
Time frame · over 12 weeks compared to baseline
Assessment of NRS
Change in Numeric Rating Scale (NRS)
Time frame · over 24 weeks compared to baseline
Assessment of NRS
Change in Numeric Rating Scale (NRS)
Time frame · over 48 weeks compared to baseline
Assessment of NRS
Change in Headache Impact Test-6 (HIT-6)
Time frame · over 12 weeks compared to baseline
Assessment of HIT-6
Change in Headache Impact Test-6 (HIT-6)
Time frame · over 24 weeks compared to baseline
Assessment of HIT-6
Change in Headache Impact Test-6 (HIT-6)
Time frame · over 48 weeks compared to baseline
Assessment of HIT-6
Change in Migraine Disability Assessment Score (MIDAS)
Time frame · over 12 weeks compared to baseline
Assessment of MIDAS
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
Italy. Showing up to 24 locations stored in the fast local snapshot.
IRCCS San Raffaele Roma
Roma, RM, Italy
Publications
Results and literature.
PMID 33280422 ↗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 32209650 ↗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 35716692 ↗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 32075406 ↗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 42262724 ↗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.
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