ProspeCtive Observational Real-world Study of uBRogepant and Atogepant in Israel (COBRA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Ubrogepant (UBRO) Only: Percentage of Participants with Responder Status of "Extremely Satisfied" or "Satisfied" on a Single Item 7-Point Scale
研究概览
简要总结
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will evaluate how effective the use of ubrogepant and atogepant is in treating adult participants with migraine.
Urogepant (Ubrelvy) and Atogepant (Qulipta) are approved drugs for treatment of migraine in adults in the US. Approximately 200 adult participants who are prescribed Ubrogepant or atogepant by their doctors will be enrolled in this study in Israel.
Participants will receive ubrogepant oral tablets or atogepant oral tablets as prescribed by their physician. Participants will be followed for 90 days.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
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
- •Confirmed diagnosis of migraine according to the ICHD-3 upon judgement of the treating physician
- •The patients should be naive to the designated treatment
- •Ability to fill an e-diary app
排除标准
- •Patients who cannot be treated with UBRO or ATO according to the applicable approved label
- •Patients participating in a concurrent clinical interventional study or within the last 30 days
- •Patients who were previously treated with rimegepant will be excluded from the study
研究组 & 干预措施
Atogepant
Participants will receive atogepant as prescribed by their physician in routine clinical practice.
Ubrogepant
Participants will receive ubrogepant as prescribed by their physician in routine clinical practice.
结局指标
主要结局
Ubrogepant (UBRO) Only: Percentage of Participants with Responder Status of "Extremely Satisfied" or "Satisfied" on a Single Item 7-Point Scale
时间窗: Baseline to Day 90
The single item 7-point scale asks the question "Overall, how satisfied are you with Ubrelvy for treatment of your migraine?" to assess change in satisfaction of migraine treatment where 0 = extremely satisfied and 6 = extremely dissatisfied.
Atogepant (ATO) Only: Percentage of Participants with Responder Status of "Extremely Satisfied" or "Satisfied" on a Single Item 7-Point Scale
时间窗: Baseline to Day 90
The single item 7-point scale asks the question "Overall, how satisfied are you with Qulipta for treatment of your migraine?" to assess change in satisfaction of migraine treatment where 0 = extremely satisfied, 1 = satisfied and 6 = extremely dissatisfied.
次要结局
未报告次要终点