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

NCT05570149 | Recruiting

• 1 other identifier: RP 177/SR/24
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine Disorders

Keywords

Eptinezumab,; Calcitonin gene-related peptide,; Effectiveness,; Real-life,; Migraine,; Safety; Treatment

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (26)

• Change in monthly analgesic intake

  over 12 weeks compared to baseline

• Change in monthly analgesic intake

  over 24 weeks compared to baseline

• Change in monthly analgesic intake

  over 48 weeks compared to baseline

• Change in Numeric Rating Scale (NRS)

  over 12 weeks compared to baseline

• Change in Numeric Rating Scale (NRS)

  over 24 weeks compared to baseline

Interventions

Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution DRUG

migraine prophylaxis

Also known as: anti CGRP monoclonal antibody

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all consecutive patients aged 18-75 affected by hight frequency or chronic migraine with or without medication overuse.

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele Roma

Roma, RM, 00163, Italy

RECRUITING

Related Publications (4)

• 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 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.

  PMID: 33280422 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.

  PMID: 32209650 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.

  PMID: 35716692 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

eptinezumab; Saline Solution

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Piero Barbanti, MD, PhD

  IRCCS San Raffaele Roma

  STUDY CHAIR

Central Study Contacts

Piero Barbanti, MD, PhD

CONTACT

+393357071457; piero.barbanti@sanraffaele.it

Cinzia Aurilia, MD

CONTACT

+393334147390; cinzia.aurilia@sanraffaele.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 6, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)