STudio Osservazionale Sull'Efficacia, Sicurezza e tollerabilità di Atogepant in Pazienti Real Life Affetti da Emicrania in Italia (Studio STAR)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Changes in migraine frequency after three months of treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Episodic migraine
Patients affected by migraine with an episodic pattern (< 15 monthly migraine days) with or without aura according to ICHD-III criteria.
干预措施: Atogepant 60 mg (Drug)
Chronic migraine
Patients affected by chronic migraine (> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria.
干预措施: Atogepant 60 mg (Drug)
结局指标
主要结局
Changes in migraine frequency after three months of treatment
时间窗: 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
时间窗: 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)
次要结局
- 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)
研究者
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