Feedback on the Use of Eptinezumab: Efficacy at 6 Months in Severe Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Concomitant treatments
研究概览
简要总结
The October 2022 Transparency Commission considers that VYEPTI (eptinezumab) is a treatment option for patients suffering from severe migraine with at least 8 migraine days per month, who have failed at least two prophylactic treatments and have no cardiovascular impairment.
Since the beginning of 2023, eptinezumab has been available in France as an inpatient treatment prescribed by a migraine neurologist in a growing number of centres. The Saint-Denis Hospital and the Nîmes University Hospital are among the first centres to have started. The investigators from these 2 centres have therefore decided to pool their data to provide the first French feedback on its effectiveness.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients suffering from severe migraine with at least 8 migraine days per month
- •Patients who have failed at least 2 disease-modifying treatments,
- •Patients treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at Saint-Denis Hospital and Nîmes University Hospital.
排除标准
- •Patient refusing to participate
结局指标
主要结局
Concomitant treatments
时间窗: 6 months
Use of concomitant crisis and background treatments (description)
HIT6 scores (disability score)
时间窗: 6 months
Evaluation of HIT6 scores (disability score), ≤ 49 headaches have little impact on daily life; between 50 and 55: headaches have some impact on daily life; 56 to 59: headaches have a significant impact on daily life; ≥ 60
HAD (anxiety/depression score)
时间窗: 6 months
Evaluation of HAD score. From 0 to 7: absence of anxiety and/or depressive disorders, from 8 to 10: doubtful symptomatology, 11 to 21: proven anxiety and/or depression disorders of varying severity.
Headaches and migraines per month
时间窗: 6 months
Number of headache and migraine days per month.
Responders
时间窗: 6 months
Rate of responders (30%, 50% and super responders \> 75%)
Duration
时间窗: 6 months
Duration of effect of eptinezumab infusion (Numbers of weeks)
次要结局
未报告次要终点