Atogepant in Real Life in Italy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Change in monthly migraine days at weeks 9-12 compared to baseline
研究概览
简要总结
Atogepant is an oral, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist that has been approved for the preventive treatment of episodic and chronic migraine (>= 4 monthly migraine days) with or without medication overuse.
详细描述
This study is designed to confirm the effectiveness and safety of atogepant in real life. The primary endpoint is the change from baseline in the mean number of monthly migraine days (MMDs)across the 12 weeks. Secondary endpoints include: change in monthly analgesic intake, Numeric Rating Scale (NRS), Headache Impact Test-6 (HIT-6) and Migraine disability assessment (MIDAS) scores, >=50%, >=75%, 100% responders, >=50%, >=75%, 100% responders in patients with medication overuse at weeks 9-12 compared to baseline and adverse events eventually occur during 12 weeks of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: >18 yrs Diagnosis of migraine Migraine frequency: >=4 monthly migraine days (MMDs)
排除标准
- •Patients using concomitant migraine prophylaxis Use of onabotulinumtoxinA during the previous 12 weeks Exposure to anti-CGRP mAbs during the previous 24 weeks Clinically significant cardiovascular disorders
结局指标
主要结局
Change in monthly migraine days at weeks 9-12 compared to baseline
时间窗: 12 weeks
variation of number of monthly migraine days
次要结局
- Change in monthly analgesic intake at weeks 9-12 compared to baseline(12 weeks)
- Change in Numerical Rating Scale (NRS) score at weeks 9-12 compared to baseline(12 weeks)
- Change in HIT-6 (Headache Impact Test) score at weeks 9-12 compared to baseline(12 weeks)
- Change in Migraine Disability Assessment Test Score (MIDAS) at weeks 1-12 compared to baseline Change in MIDAS (Migraine Disability Assessment Score) score at weeks 9-12 compared to baseline(12 weeks)
- >50%, >75%, 100% responders at weeks 9-12 compared to baseline(12 weeks)
- >50%, >75%, 100% responders at weeks 9-12 compared to baseline in patients with Medication overuse(12 weeks)
- adverse events(12 weeks)