The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of atogepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients.
Atogepant is a small molecule calcitonin gene- related peptide (CGRP) receptor antagonist, part of the gepants family. It is a second generation gepant, currently approved for the preventive treatment of episodic and chronic migraine. Previously randomized, placebo-controlled phase 2/3 trials demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine, associated with a good tolerability profile. The most commonly reported adverse events were upper respiratory tract infections, urinary infections, nausea and constipation. In this prospective multicentric study the investigators aim to evaluate atogepant 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. patients will take atogepant 60 mg daily for at least 12 weeks up to two years, according to effectiveness, tolerability and eventual approval of reimbursability criteria. Data will be collected at baseline and every three months for 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. The online database REDCap will be used for data collection.
Study Type
OBSERVATIONAL
Enrollment
500
Patients using atogepant 60 mg tablet daily as migraine prevention
SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
Florence, Italy
Fondazione Policlinico Campus Bio-Medico
Roma, Italy
Changes in migraine frequency after three months of treatment
Changes in monthly migraine days after three months of treatment with atogepant compared to baseline (continuous variable)
Time frame: Baseline (T0) - 3 months of treatment with atogepant (T3)
50% Response 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 atogepant (continuous variable)
Time frame: Baseline (T0) - 3 months of treatment with atogepant (T3)
Changes in migraine frequency across twelve months of atogepant treatment
Changes in monthly migraine days after six and twelve months of treatment with atogepant compared to baseline (continuous variable)
Time frame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with atogepant
Percentage of 50% Responders (namely patients who presented a reduction of MMDs \>/ = 50% compared to baseline) after six and twelve months of treatment with atogepant (continuous variable)
Time frame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Evaluation of any adverse event (qualitative)
Type of any adverse events in patients receiving atogepant during the observation period (categorical variable)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Evaluation of any adverse event (quantitative)
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Percentage of reported adverse events in patients receiving atogepant assessed quarterly during the observation period (continuous variable)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Evaluation of serious adverse event
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 atogepant during the observation period (continuous variable)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Evaluation of adverse event leading to treatment discontinuation
Percentage of adverse events leading to treatment discontinuation in patients receiving atogepant during the observation period (continuous variable)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Consistency of treatment response
Percentage of patients with a stable 50% response across twelve months of atogepant treatment (continuous variable)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Changes in migraine disability (MIDAS)
Changes in MIgraine Disability ASsement 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: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
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: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Changes in response to acute migraine treatment (m-TOQ)
Changes in migraine Treatment Optimization Questionnaire across treatment (continuous variable, 0-8 scale, higher score indicates higher acute therapy effectiveness)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
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: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Changes in quality of life across atogepant treatment (MSQ)
Changes in Migraine Specific Quality of life questionnaire across treatment (continuous variable, 0-100 scale, 100 indicates full functionality)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Changes in interictal burden across atogepant 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: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
Self-reported treatment effectiveness
Changes in Migraine Assessment of Current Therapy (Migraine-ACT) a 4-item questionnaire about treatment effectiveness and daily life repercussions, across treatment compared to baseline (continuous variable, 0-4 scale, higher scores indicates higher acute treatment effectiveness)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant
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 treatment (continuous variable)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant