A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Treatment Satisfaction Questionnaire for Medication (TSQM)
研究概览
简要总结
This study is a single-arm, prospective, multicenter, observational registry study. It plans to enroll 120 migraine patients who meet the inclusion criteria and are treated with rimegepant in selected hospital outpatient clinics in the Greater Bay Area. The main purpose of this study is to observe the effectiveness of rimegepant in treating migraines in a real-world clinical setting, including the impact of rimegepant on the quality of life, functioning, productivity status of migraine patients, and patients' satisfaction with the use of rimegepant in treating migraines.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with headaches that meet the diagnostic criteria for migraines according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), with or without aura.
- •Patients prescribed rimegepant by the attending physician for the treatment of migraines.
- •Signed informed consent form.
- •Age greater than 18 years.
- •Not concurrently participating in other interventional clinical studies.
排除标准
- •Patients diagnosed with secondary headaches.
- •Patients with severe visual, auditory, language, intellectual, memory, consciousness impairments or other conditions that prevent them from completing the questionnaire and follow-up.
- •Pregnant or lactating female patients.
- •Patients deemed by the investigator as unsuitable for participation in the study or unable to complete the 4-week follow-up.
- •Patients with a known history of hypersensitivity reactions to rimegepant or its components.
- •Evidence in the medical history suggesting the presence of uncontrolled or unstable cardiovascular diseases (such as ischemic heart disease, coronary artery vasospasm, or cerebrovascular ischemia), or a history of myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke, or transient ischemic attack within the past 6 months before the screening visit.
结局指标
主要结局
Treatment Satisfaction Questionnaire for Medication (TSQM)
时间窗: 4 weeks
Treatment Satisfaction Questionnaire for Medication (TSQM) score for migraine patients' satisfaction with treatment of rimegepant
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)
时间窗: 4 weeks
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) score for the impact of rimegepant on the quality of life of migraine patients
Work Productivity and Activity Impairment-General Health (WPAI-GH)
时间窗: 4 weeks
Work Productivity and Activity Impairment-General Health (WPAI-GH) score for the impact of rimegepant on the productivity and work efficiency of migraine patients
Headache Impact Test-6 (HIT-6)
时间窗: 4 weeks
Headache Impact Test-6 (HIT-6) score for the impact of rimegepant on the functioning of migraine patients
次要结局
未报告次要终点