Chronic Migraine, Migraine, Migraine With Aura, Migraine Without Aura
Conditions
Keywords
Headache, Medication overuse headache, Pain, Migraine prevention, Anti-CGRP monoclonal antibodies, eptinezumab
Brief summary
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.
Detailed 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.
Interventions
Patients administered eptinezumab 100 or 300 mg ev quarterly for migraine prevention
Sponsors
University of Florence
Azienda Ospedaliero Universitaria Policlinico Modena
Società Italiana per lo Studio delle Cefalee
IRCCS National Neurological Institute "C. Mondino" Foundation
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Università degli Studi dell'Aquila
University of Roma La Sapienza
Euganea Health Unit, Padua, Italy
Azienda Ospedaliero-Universitaria di Parma
Azienda Ospedaliera S. Maria della Misericordia
A.O.U. Città della Salute e della Scienza
Cliniche Humanitas Gavazzeni
University of Campania Luigi Vanvitelli
Ospedale Santo Stefano
Azienda Policlinico Umberto I
Auxologico San Luca
Asst Degli Spedali Civili Di Brescia
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in migraine frequency after three months of treatment | Baseline (T0) - 3 months of treatment with eptinezumab (T3) | Changes in monthly migraine days after three months of treatment with eptinezumab compared to baseline (continuous variable) |
| Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment | 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 with eptinezumab (continuous variable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in migraine frequency across twelve months of eptinezumab treatment | Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab | Changes in monthly migraine days after six and twelve months of treatment with eptinezumab compared to baseline (continuous variable) |
| Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with eptinezumab | 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) after six and twelve months of treatment with eptinezumab (continuous variable) |
| Evaluation of any adverse event (qualitative) | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab | Type of any adverse events in patients receiving eptinezumab during the observation period (categorical variable) |
| Evaluation of any adverse event (quantitative) | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab | Percentage of reported adverse events in patients receiving eptinezumab assessed quarterly during the observation period (continuous variable) |
| Evaluation of serious adverse events | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab | 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) |
| Evaluation of adverse events leading to treatment discontinuation | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab | Percentage of adverse events leading to treatment discontinuation in patients receiving eptinezumab during the observation period (continuous variable) |
| Consistency of treatment response | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab | Percentage of patients with a stable 50% response across twelve months of eptinezumab treatment (continuous variable) |
| Changes in migraine disability (MIDAS) | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab | 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) |
| Changes in migraine disability (HIT-6) | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab | Changes in Headache Impact Test-6 questionnaire across treatment (continuous variable, 36-78 scale, higher scores indicates greater disability) |
| Changes in response to acute migraine treatment (m-TOQ) | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab | Changes in migraine Treatment Optimization Questionnaire across eptinezumab treatment (continuous variable, 0-8 scale, higher score indicates higher acute therapy effectiveness) |
| Changes in allodynia (ASC-12) | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab | Changes in Allodynia Symptoms Checklist-12 questionnaire across treatment (continuous variable, 0-24 scale, higher score indicates more severe allodynia) |
| Changes in interictal burden across eptinezumab treatment (MIBS-4) | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab | 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) |
| Percentage of patients with Medication overuse headache reverted during treatment | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab | Percentage of patients with a baseline diagnosis of MOH reverted after 3 - 6 and 12 months of eptinezumab treatment (continuous variable) |
Countries
Italy
Outcome results
None listed