German Real-World Evidence Study on the Effectiveness of Foslevodopa/Foscarbidopa at Initial Stages of Advanced Parkinson's Disease: Motor Symptoms, Quality of Life, Psychosocial Functioning and Work Ability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 32
- 主要终点
- Change From Baseline in OFF Time (hours)
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 German adult participants at initial stages of advanced Parkinson's disease under routine clinical practice.
Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 125 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 20 sites in Germany.
Participants will receive Foslevodopa/Foscarbidopa 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a diagnosis of levodopa-responsive idiopathic Parkinson's disease
- •Eligibility for foscarbidopa/foslevodopa (LDp/CDp) therapy in accordance with the approved local label
- •Participant must be an adult male or female, 18-64 years of age
- •Time since beginning of motor fluctuations ≤ 3 years
- •The Hoehn and Yahr (H&Y) stage < 3 in the on-medication condition
- •Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in this study
排除标准
- •Previous Exposure to any device-aided therapy (DAT).
- •Any condition included in the contraindications section of the approved local LDp/CDp label.
- •Participants with Mini mental state examination (MMSE) score < 24
结局指标
主要结局
Change From Baseline in OFF Time (hours)
时间窗: Up To 12 months
The mean change from baseline to each scheduled visit in the number of hours spent in OFF time will be estimated using a mixed-effect model repeated-measures (MMRM).
次要结局
未报告次要终点