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

Migraine Disorders Clinical Trial

— EMBRACE  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570149
• Other study ID #: IRCCS San Raffaele Roma
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: IRCCS San Raffaele Roma
• Contact: Piero Barbanti, MD, PhD
• Phone: +393357071457
• Email: piero.barbanti[@]sanraffaele.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Roma	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele Roma

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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: 10.1177/033310242090 — View 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. Erratum In: Neurology. 2023 Aug 8;101(6):283. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline in MMD in HFEM or MHD in CM;	assessment of MMD or MHD	over 24 weeks of treatment compared to baseline
Primary	Change from baseline in MMD in HFEM or MHD in CM;	assessment of MMD or MHD	over 48 weeks of treatment compared to baseline
Primary	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
Secondary	Change in monthly analgesic intake	Assessment of monthly analgesic intake	over 12 weeks compared to baseline
Secondary	Change in monthly analgesic intake	Assessment of monthly analgesic intake	over 24 weeks compared to baseline
Secondary	Change in monthly analgesic intake	Assessment of monthly analgesic intake	over 48 weeks compared to baseline
Secondary	Change in Numeric Rating Scale (NRS)	Assessment of NRS	over 12 weeks compared to baseline
Secondary	Change in Numeric Rating Scale (NRS)	Assessment of NRS	over 24 weeks compared to baseline
Secondary	Change in Numeric Rating Scale (NRS)	Assessment of NRS	over 48 weeks compared to baseline
Secondary	Change in Headache Impact Test-6 (HIT-6)	Assessment of HIT-6	over 12 weeks compared to baseline
Secondary	Change in Headache Impact Test-6 (HIT-6)	Assessment of HIT-6	over 24 weeks compared to baseline
Secondary	Change in Headache Impact Test-6 (HIT-6)	Assessment of HIT-6	over 48 weeks compared to baseline
Secondary	Change in Migraine Disability Assessment Score (MIDAS)	Assessment of MIDAS	over 12 weeks compared to baseline
Secondary	Change in Migraine Disability Assessment Score (MIDAS)	Assessment of MIDAS	over 24 weeks compared to baseline
Secondary	Change in Migraine Disability Assessment Score (MIDAS)	Assessment of MIDAS	over 48 weeks compared to baseline
Secondary	Change in Migraine interictal burden (MIBS-4)	Assessment of MIBS-4	over 12 weeks compared to baseline
Secondary	Change in Migraine interictal burden (MIBS-4)	Assessment of MIBS-4	over 24 weeks compared to baseline
Secondary	Change in Migraine interictal burden (MIBS-4)	Assessment of MIBS	over 48 weeks compared to baseline
Secondary	Change in Patient Global Impression of change (PGIC) scale	Assessment of MIBS	over 12 weeks compared to baseline
Secondary	Change in Patient Global Impression of change (PGIC) scale	Assessment of MIBS	over 24 weeks compared to baseline
Secondary	Change in Patient Global Impression of change (PGIC) scale	Assessment of MIBS	over 48 weeks compared to baseline
Secondary	=50%, =75% and 100% response rates	Assessment of responder rates	over 12 weeks compared to baseline
Secondary	=50%, =75% and 100% response rates	Assessment of responder rates	over 24 weeks compared to baseline
Secondary	=50%, =75% and 100% response rates	Assessment of responder rates	over 48 weeks compared to baseline
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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