NCT05709106已完成不适用
A Prospective Real World Study of Rimegepant in the Treatment of Migraine
Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine1 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2023年1月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Change From Baseline on the percentage of participants that are pain relief at 2 hours post-dose during the migraine attack
研究概览
简要总结
The goal of this observational study is to test the effectiveness and safety of Rimegepant in the treatment of migraine patients in real world.
The main questions it aims to answer are:
- [question 1] the effectiveness and safety of Rimegepant in the acute treatment of migraine
- [question 2] the effectiveness and safety of Rimegepant in the long-term treatment of migraine.
- Participants will be asked to take Rimegepant when they need to treat or prevent a migraine attack.
- Participants will be asked to record the efficacy data at 0.5, 1, 2, 24, 48h post dose and report any AE to evaluate the effectiveness and safety of Rimegepant in the acute treatment of migraine
- Participants will be asked to track monthly migraine days and the use of Rimegepant, finish 2 PROs during the follow-ups, report any AE to evaluate the effectiveness and safety of Rimegepant in the long-term treatment of migraine.
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
- •Subjects diagnosed as migraines (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, beta version
- •Rimegepant is prescribed by the physician for the treatment of patients with migraine.
- •Patients signed written informed consent.
- •Male and Female subjects ≥ 18 years and older
- •Patients is not participated in other concurrent interventional clinical studies.
排除标准
- •The patients with severe visual, hearing, language, intelligence, memory, and consciousness disorders, are unable to cooperate with the completion of the questionnaire and follow-up.
- •Pregnant patients
- •Lactating female patients
- •Patients who are highly dependent on medical care.
研究组 & 干预措施
Rimegepant treatment group
this group would use Rimegepant 75mg ODT, use it when needed for 1year
干预措施: Rimegepant 75 MG (Drug)
结局指标
主要结局
Change From Baseline on the percentage of participants that are pain relief at 2 hours post-dose during the migraine attack
时间窗: Difference between baseline and 2 hours post-dose of Rimegepant
Pain Relief at 2 hours post-dose will be assessed using the number of subjects that report a pain level of moderate or severe at baseline and then report a pain level of none or mild at two hours post-dose.
次要结局
- Change From Baseline on the percentage of participants that are freedom from Most Bothersome Symptoms MBS (nausea, phonophobia or photophobia) at 0.5,1,2,24 and 48 hours post-dose during the migraine attack(Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant)
- Change From Baseline on the percentage of subjects able to function normally, at 0.5, 1, 2, 24 and 48 hours post-dose, will be accessed by the Functional Disability scale(Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant)
- Change From Baseline on the percentage of participants that are pain freedom at 0.5,1, 2, 24 and 48 hours post-dose during the migraine attack(Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant)
- Change From Baseline in the Mean Number of Migraine Days Per Month Over the 12 months follow-up period.(From baseline to 12 months follow-up period)
- Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v 2.1 (MSQ) total score and Headache Impact Test (HIT-6) total score at month 3,6,12 in the 12 months follow-up(From baseline and month 3,6,12 in the 12 months follow-up)
- Change From Baseline on percentage of participants that are pain relief at 0.5,1,24 and 48 hours post-dose during the migraine attack(Difference between baseline and 0.5, 1, 24 and 48 hours post-dose of Rimegepant)
研究者
研究点 (1)
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