Real-life Study of the Efficacy of Management of Migraine Patients After Failure of 2 Prophylactic Treatments: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Headache Impact Test in patients with migraine at 12 months
研究概览
简要总结
This is a real-life, observational, single-center cohort study to describe the efficacy of prophylactic treatment in patients after failure of at least 2 prophylactic treatments. Patients included in the study will be followed up in consultations or day hospitals according to their usual care, and will be asked to complete the MIgraine Disability Assessment (MIDAS), Headache Impact Test short-form (HIT-6), Patient Global Impression of Change (PGIC), Hospital Anxiety and Depression (HAD) scale and Work and Personal Activities Impairment (WPAI) questionnaires at each visit.
Data describing their care will be extracted from computerized patient records.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with Migraine [International Headache Society (IHS) criteria 2013, revised 2018] with or without aura
- •Monthly number of attacks ≥ 8 for at least 3 months
- •Indication for prophylactic treatment
- •For eptinezumab: resistance to at least 2 conventional disease-modifying therapies
- •Agrees to use data for research purposes
排除标准
- •Vascular history: myocardial infarction (MI), unstable angina or coronary bypass surgery, stroke or transient ischemic attack (TIA), Peripheral Arterial Disease of the Lower Limbs (PAD), uncontrolled hypertension
- •Need for analgesics for a cause other than migraine
- •Difficulty in understanding French language or cognitive impairment that compromises completion of self-questionnaires.
结局指标
主要结局
Headache Impact Test in patients with migraine at 12 months
时间窗: 12 months after prophylactic treatments
Using HIT-6 (Headache Impact Test short-form) questionnaire which addresses six main domains affected by headaches, including pain, social functioning, role functioning, cognitive functioning, vitality and psychological stress. This survey is extremely useful for screening and monitoring how headaches affect patients in their day-to-day lives over time. Each item is answered on a 5-point Likert scale (6 = never, 8 = rarely, 10 = sometimes, 11 = very often, 13 = always). The scoring of the HIT-6 was derived to approximate the total score obtained from a larger battery of items, using results from item response theory (IRT) \[10\]. The final score is obtained from simple summation of the six items.
次要结局
- Migraine occurence in patients with migraine at 12 months(12 months after prophylactic treatments)
- Anxiety and Depression state evaluation in patients with migraine at 12 months(12 months after prophylactic treatments)
- Patient Global Impression of Change in patients with migraine at 12 months(12 months after prophylactic treatments)
- Headache-related disability in patients with migraine at 12 months(12 months after prophylactic treatments)
- Days off work at 12 months(12 months after prophylactic treatments)
- Emergency room visits at 12 months(12 months after prophylactic treatments)
- Crisis treatments in patients with migraine at 12 months(12 months after prophylactic treatments)
- Work and Personal Activities Impairment in patients with migraine at 12 months(12 months after prophylactic treatments)
- Most Bothersome Symptom in patients with migraine at 12 months(12 months after prophylactic treatments)
- Type of prophylactic treatment used at 12 months(12 months after prophylactic treatments)