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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Patients administered eptinezumab 100 or 300 mg ev quarterly for migraine prevention
SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
Florence, Italy
RECRUITINGAOU Policlinico Di Modena
Modena, Italy
NOT_YET_RECRUITINGChanges in migraine frequency after three months of treatment
Changes in monthly migraine days after three months of treatment with eptinezumab compared to baseline (continuous variable)
Time frame: Baseline (T0) - 3 months of treatment with eptinezumab (T3)
Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment
Percentage of 50% Responders (namely patients who presented a reduction of MMDs \>/ = 50% compared to baseline) after three months of treatment with eptinezumab (continuous variable)
Time frame: Baseline (T0) - 3 months of treatment with eptinezumab (T3)
Changes in migraine frequency across twelve months of eptinezumab treatment
Changes in monthly migraine days after six and twelve months of treatment with eptinezumab compared to baseline (continuous variable)
Time frame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with eptinezumab
Percentage of 50% Responders (namely patients who presented a reduction of MMDs \>/ = 50% compared to baseline) after six and twelve months of treatment with eptinezumab (continuous variable)
Time frame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Evaluation of any adverse event (qualitative)
Type of any adverse events in patients receiving eptinezumab during the observation period (categorical variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Simona Guerzoni, MD
CONTACT
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Evaluation of any adverse event (quantitative)
Percentage of reported adverse events in patients receiving eptinezumab assessed quarterly during the observation period (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Evaluation of serious adverse events
Percentage of serious adverse events (namely those resulting in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect) in patients receiving eptinezumab during the observation period (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Evaluation of adverse events leading to treatment discontinuation
Percentage of adverse events leading to treatment discontinuation in patients receiving eptinezumab during the observation period (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Consistency of treatment response
Percentage of patients with a stable 50% response across twelve months of eptinezumab treatment (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Changes in migraine disability (MIDAS)
Changes in MIgraine Disability ASsesment questionnaire across treatment (continuous variable, 0-270 scale, higher scores indicate higher disability: 0-5, little/no disability; 6-10, mild disability; 11-20, moderate disability; \>20, severe disability)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Changes in migraine disability (HIT-6)
Changes in Headache Impact Test-6 questionnaire across treatment (continuous variable, 36-78 scale, higher scores indicates greater disability)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Changes in response to acute migraine treatment (m-TOQ)
Changes in migraine Treatment Optimization Questionnaire across eptinezumab treatment (continuous variable, 0-8 scale, higher score indicates higher acute therapy effectiveness)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Changes in allodynia (ASC-12)
Changes in Allodynia Symptoms Checklist-12 questionnaire across treatment (continuous variable, 0-24 scale, higher score indicates more severe allodynia)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Changes in interictal burden across eptinezumab treatment (MIBS-4)
Changes in Migraine Interictal Burden Scale-4 questionnaire across treatment (continuous variable, 0-4 scale, 0 indicates no interictal burden, 1-2 mild level of interictal burden, 3 moderate interictal burden, 4 severe interictal burden)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Percentage of patients with Medication overuse headache reverted during treatment
Percentage of patients with a baseline diagnosis of MOH reverted after 3 - 6 and 12 months of eptinezumab treatment (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab