STudio Osservazionale Sull'Efficacia, Sicurezza e tollerabilità di Atogepant in Pazienti Real Life Affetti da Emicrania in Italia (Studio STAR)
Overview
- Phase
- Not Applicable
- Intervention
- Atogepant 60 mg
- Conditions
- Migraine
- Sponsor
- University of Florence
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Changes in migraine frequency after three months of treatment
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Luigi Francesco Iannone
Researcher at the Headache Center and Clinical Pharmacology Unit and at the Department of Health Sciences, University of Florence, Principal Investigator
University of Florence
Eligibility Criteria
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);
- •At least 3 monthly migraine days;
- •Good compliance to study procedures;
- •Availability of headache diary at least of the preceding months before enrollment.
Exclusion Criteria
- •Subjects with contraindications for use of gepants;
- •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.
Arms & Interventions
Episodic migraine
Patients affected by migraine with an episodic pattern (\< 15 monthly migraine days) with or without aura according to ICHD-III criteria.
Intervention: Atogepant 60 mg
Chronic migraine
Patients affected by chronic migraine (\> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria.
Intervention: Atogepant 60 mg
Outcomes
Primary Outcomes
Changes in migraine frequency after three months of treatment
Time Frame: Baseline (T0) - 3 months of treatment with atogepant (T3)
Changes in monthly migraine days after three months of treatment with atogepant compared to baseline (continuous variable)
50% Response after three months of treatment
Time Frame: Baseline (T0) - 3 months of treatment with atogepant (T3)
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)
Secondary Outcomes
- Consistency of treatment response(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant)
- Changes in allodynia (ASC-12)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant)
- Changes in migraine disability (HIT-6)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant)
- Changes in migraine frequency across twelve months of atogepant treatment(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(Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with atogepant)
- Evaluation of any adverse event (qualitative)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant)
- Evaluation of any adverse event (quantitative)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant)
- Evaluation of serious adverse event(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant)
- Changes in migraine disability (MIDAS)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant)
- Evaluation of adverse event leading to treatment discontinuation(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant)
- Changes in response to acute migraine treatment (m-TOQ)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant)
- Changes in interictal burden across atogepant treatment (MIBS-4)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant)
- Self-reported treatment effectiveness(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(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant)
- Changes in quality of life across atogepant treatment (MSQ)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant)