EptinezuMaB in ReAl-world evidenCE: a 12-Months, Multicenter, Real-Life, Cohort Study in High-Frequency Episodic and Chronic Migraine (the EMBRACE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;
研究概览
简要总结
The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.
详细描述
Eptinezumab is an humanized IgG1 and the only antiCGRP mAb administered intravenously by a quarterly dosing regimen. In randomized-controlled studies (RCTs), eptinezumab proved to be effective in preventing episodic and chronic migraine even in patients with 2 to 4 prior preventive failures and in shortening the time to complete migraine freedom when infused during a moderate-to severe migraine attack. Eptinezumab 100 mg can be used for the first administration and later if deemed necessary, the dose upgraded to 300 mg.
EMBRACE is a multicenter, prospective, cohort, real-life study carried out in Italian headache centers. Consecutive patients with high frequency episodic (HFEM: ≥8 migraine days/month) or CM (≥15 headache days/month), according to The International Classification of Headache Disorders, 3rd edition (ICHD-III), referred to participating centers. The aim of this study is to assess effectiveness, safety and tolerability of eptinezumab 100 mg iv or 300 mg iv with a quarterly dosing regimen in a real-world migraine patients population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;
时间窗: over 12 weeks of treatment compared to baseline
assessment of MMD or MHD
Change from baseline in MMD in HFEM or MHD in CM;
时间窗: over 48 weeks of treatment compared to baseline
assessment of MMD or MHD
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: over 12 months of treatment compared to baseline
assessment of occurrence of Treatment-Emergent Adverse Events
次要结局
- Change in monthly analgesic intake(over 48 weeks compared to baseline)
- Change in Numeric Rating Scale (NRS)(over 48 weeks compared to baseline)
- Change in Headache Impact Test-6 (HIT-6)(over 48 weeks compared to baseline)
- Change in Migraine Disability Assessment Score (MIDAS)(over 48 weeks compared to baseline)
- Change in Migraine interictal burden (MIBS-4)(over 48 weeks compared to baseline)
- Change in Patient Global Impression of change (PGIC) scale(over 48 weeks compared to baseline)
- ≥50%, ≥75% and 100% response rates(over 48 weeks compared to baseline)
- Percentage of migraine free patients on the day after dosing (infusion of eptinezumab)(the day after infusion of eptinezumab (second infusion of eptinezumab))
- Proportion of patients with medication overuse at baseline reverting to no medication overuse(over 48 weeks compared to baseline)