Effectiveness and Tolerability of Eptinezumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-26

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Migraine Migraine With Aura Migraine Without Aura Chronic Migraine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Episodic migraine

Patients affected by migraine with an episodic pattern (\< 15 monthly migraine days) with or without aura according to ICHD-III criteria.

Eptinezumab 100 or 300 mg ev

Intervention Type DRUG

Patients administered eptinezumab 100 or 300 mg ev quarterly for migraine prevention

Chronic migraine

atients affected by chronic migraine (\> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria.

Eptinezumab 100 or 300 mg ev

Intervention Type DRUG

Patients administered eptinezumab 100 or 300 mg ev quarterly for migraine prevention

Interventions

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Eptinezumab 100 or 300 mg ev

Patients administered eptinezumab 100 or 300 mg ev quarterly for migraine prevention

Intervention Type DRUG

Other Intervention Names

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Eptinezumab

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Luigi Francesco Iannone

Researcher at the Headache Center and Clinical Pharmacology Unit and the Department of Health Sciences, University of Florence, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR