Effectiveness aNd Use of fosleVOdopa-foscarbidopa in Advanced Parkinson Disease in Real Life Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 61
- 主要终点
- Change From Baseline in Parkinson's Disease Questionnaire-8 (PDQ) total score.
研究概览
简要总结
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how effective foscarbidopa/ foslevodopa is in treating French adult participants with advanced Parkinson disease under routine clinical practice.
Foslevodopa/foscarbidopa is an approved drug outside of US for the treatment of Parkinson's Disease. Approximately 200 adult participants who are prescribed foslevodopa/foscarbidopa by their doctors will be enrolled across approximately 30 sites in France.
Participants will receive foscarbidopa/ foslevodopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 months.
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
- •Participants with advanced Parkinson disease with motor complications insufficiently controlled by current therapy
- •Participants eligible for foscarbidopa / foslevodopa according to French label & regulation.
- •Treatment initiation decision prior to and independently from study enrolment
排除标准
- •Participants with any contraindication to foscarbidopa / foslevodopa.
- •Participants with Mini mental state examination (MMSE) score < 24
研究组 & 干预措施
Foscarbidopa / Foslevodopa
Participants will receive foscarbidopa/ foslevodopa as prescribed by their physician according to local label
结局指标
主要结局
Change From Baseline in Parkinson's Disease Questionnaire-8 (PDQ) total score.
时间窗: Up to approximately 12 months
Parkinson Disease Questionnaire (PDQ)-8 is an eight-question instrument constructed by taking one question from each domain of PDQ-39: mobility, activities of daily of living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Each question is scored between 0 and 4 as follows: 0=Never and 4 = Always or cannot do at all. A higher score signifies poorer quality of life.
次要结局
未报告次要终点