A Post-marketing Observational Study for ABBV-951 in Patients Diagnosed With Advanced Parkinson's Disease (aPD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 33
- 主要终点
- Percentage of Participants Experiencing Infusion Site Infections
研究概览
简要总结
Parkinson's disease (PD) is a neurological condition, which affects the brain. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to assess how safe and effective ABBV-951 is in treating participants with Parkinson's disease in real world setting.
ABBV-951 is an approved drug being developed for the treatment of PD in Japan. Approximately 250 adult participants over 15 years with a diagnosis of PD who are prescribed ABBV-951 by their physicians will be enrolled in this study across Japan.
Participants will receive ABBV-951 as prescribed their physician and followed for 52 weeks.
There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with advanced Parkinson's disease (aPD).
- •Prescribed ABBV-951 as physicians' decision according to the approved label for treatment of aPD.
- •Given informed consent (or by her/his legal representative, if it's a requirement from the participating hospital/clinic) for participating this study.
排除标准
- •Prior treatment with ABBV-951 for PD.
- •Currently participating in interventional clinical trials.
结局指标
主要结局
Percentage of Participants Experiencing Infusion Site Infections
时间窗: Up to 52 Weeks
Percentage of participants with infusion site infections following the commencement of ABBV-951 will be assessed.
次要结局
未报告次要终点