Effectiveness and Tolerability of Eptinezumab (TACHIS)

University of Florence (UNIFI)

Status

Enrolling

Conditions

Migraine With Aura

Chronic Migraine

Migraine Without Aura

Migraine

Treatments

Drug: Eptinezumab 100 or 300 mg ev

Study type

Observational

Funder types

Other

Identifiers

NCT06409845

RICe_5

Details and patient eligibility

About

The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of eptinezumab as preventive migraine treatment in a cohort of episodic or chronic migraine patients.

Full description

Eptinezumab belongs to the monoclonal antibodies directed against the calcitoning gene related peptide - CGRP (mAbs). It is actually the only mAb administered intravenously, currently available at the dose of 100 or 300mg with a quarterly iv infusion.

It has an indication for migraine prevention for episodic and chronic migraine. Previous randomized, placebo-controlled clinical trials proved its effectiveness in the preventive setting for patients with episodic and chronic migraine.

Moreover, a previous study also supported evidence of faster headache pain freedom and most bothersome symptom resolution after eptinezumab 100mg infusion during migraine acute attack compared to placebo.

RCTs also demonstrated a good tolerability profile. The most commonly reported adverse events were mainly upper respiratory tract infections, fatigue and hypersensitivity reactions.

In this prospective multicentric study the investigators aim to evaluate eptinezumab effectiveness and tolerability as preventive migraine treatment in a real-world setting.

Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline demographic and clinical data will be collected at the baseline visit. The observation period will last for two years during which patients will be administered eptinezumab 100 or 300 mg according to clinicians' judgment, for a time period related to Italian Medicines Agency reimbursability criteria.

Data will be collected at baseline and every three months, up to two years. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Questionnaires will be collected every three months.

Data collection will focus on: i) demographic data, ii) migraine history, iii) pain intensity, iv) presence and evolution of migraine associated symptoms and aura, v) migraine associated disability, vi) tolerability and eventual treatment- emergent adverse events, vii) treatment persistence, viii) questionnaires related to disability, allodynia, quality of life, interictal burden and effectiveness of the ongoing acute and preventive treatments. The online database REDCap will be used for data collection.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III);
Good compliance to study procedures;
Availability of headache diary at least of the preceding months before enrolment;
At least 8 monthly migraine days.

Exclusion criteria

Subjects with contraindications for use of eptinezumab;
Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments;
medical comorbidities that could interfere with study results;
Pregnancy and breastfeeding
Changes in preventive treatments in the month before the first administration of eptinezumab