Exploring Eptinezumab: Unveiling Peripheral and Central Mechanisms of Action and Searching for Biomarkers of Patient Response (EUPHORIA Study)

Trial details

Who runs it

Ospedale San Raffaele S.r.l.

Trial code

EU 2024-519337-35-00

Record updated

2026. február 10.

Original description

1. To identify reference values specific to migraine for measures of central and peripheral sensitization. 2. To identify treatment-induced changes in measures of central and/or peripheral sensitization, from baseline to week 12 of eptinezumab 100mg, and to explore correlation between treatment-induced changes in candidate measures of sensitization and clinical efficacy measures at 12 weeks of treatment with eptinezumab 100mg (analysis: changes intra patients treated with eptinezumab 100mg).Read full original descriptionShow less

1. To identify reference values specific to migraine for measures of central and peripheral sensitization. 2. To identify treatment-induced changes in measures of central and/or peripheral sensitization, from baseline to week 12 of eptinezumab 100mg, and to explore correlation between treatment-induced changes in candidate measures of sensitization and clinical efficacy measures at 12 weeks of treatment with eptinezumab 100mg (analysis: changes intra patients treated with eptinezumab 100mg).

Inclusion: Individuals aged ≥ 18 years; Healthy controls aged ≥ 18 years; Healthy controls right-handedness; Healthy controls able to autonomously sign the informed consent prior to study enrolment; Right-handedness; Able to autonomously sign the informed consent prior to study enrolment; History of migraine with or without aura for at least 12 months prior to study enrolment, based on the diagnostic criteria of the International Classification of Headache Disorders version 3rd edition (ICHD-3)1, as determined from medical records and/or migraine participants self-report; Eligibility for treatment with eptinezumab according to the current reimbursement policies of the Italian Health System; Migraine frequency of ≥8 migraine days per month on average across the three months prior to study enrolment; Failure to respond to three or more previous preventive treatments, including tricyclics, anticonvulsants, beta-blockers, and onabotulinum toxin A, due to either lack of efficacy or poor tolerability. Efficacy failure is defined as no reduction in headache and migraine frequency, duration, or severity after administering the respective medication for at least 6 weeks at approved therapeutic dose(s). Tolerability failure is defined as documented discontinuation due to adverse events of the respective medication at any time prior to screening; Migraine-related disability as moderate or severe according to the Migraine Disability Assessment (MIDAS) questionnaire; Female subjects of childbearing potential must practice at least one of the following specified method of birth control during the study: combined (estrogen and progestogen containing) hormonal birth control (oral, intravaginal, transdermal, injectable); progestogen-only hormonal birth control (oral, injectable, implantable); bilateral tubal occlusion/ligation; intrauterine device; intrauterine hormone-releasing system; vasectomized partner; practice true abstinence, a barrier method (male condom or female condom) with or without spermicide or cap, diaphragm or sponge with spermicide.

Exclusion: Currently receiving more than one other prophylactic treatment for migraine; Currently using other preventive treatment targeting the CGRP pathway; Currently using acute treatments targeting the CGRP pathway; Evidence of drug or alcohol abuse or dependence within 12 months prior to study enrolment in healthy controls; Evidence of drug or alcohol abuse or dependence within 12 months prior to study enrolment; History of medication overuse headache according to the ICHD-3 criteria1; History of any headaches except for infrequent tension-type headache for healthy controls; Cardio or cerebrovascular comorbidities, such as myocardial infarction, stroke, transient ischemic attack, unstable angina in healthy controls; Cardio or cerebrovascular comorbidities, such as myocardial infarction, stroke, transient ischemic attack, unstable angina; Poor controlled blood hypertension in healthy controls; Other chronic pain disorders and neuropathic pain in healthy controls; History of head trauma or seizure or major psychiatric disorders or suicidal ideation/behaviour in healthy controls; Clinical conditions contraindicating a MRI scan, such as pacemakers, aneurysm clips, artificial heart valves, ear implants, foreign metal objects in the eyes, skin, or body, or any other condition deemed hazardous in combination with MRI, in healthy controls; Poor controlled blood hypertension; Other chronic headache conditions, such as cluster headache, hemiplegic migraine headache or persistent post-traumatic headache; Other chronic pain disorders and neuropathic pain; History of head trauma or seizure or major psychiatric disorders or suicidal ideation/behaviour; Clinical conditions contraindicating a MRI scan, such as pacemakers, aneurysm clips, artificial heart valves, ear implants, foreign metal objects in the eyes, skin, or body, or any other condition deemed hazardous in combination with MRI; Age older than 50 years at migraine onset; Needle phobia; Unable to differentiate migraine from other headaches; Use of one migraine preventive treatment without a stable dosage for the last two months; Needle phobia for healthy controls; For females healthy controls, pregnancy or breastfeeding; For females, pregnancy or breastfeeding.

EU CTIS 2024-519337-35-00