NCT03733496已完成不适用
An Observational, Long-Term Extension Study for Participants in Prior VY-AADC01 Clinical Studies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
An extension study for participants who have completed a prior VY-AADC01 clinical study
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed participation in the PD-1101 or PD-1102 clinical study of VY-AADC01 gene therapy
排除标准
- 未提供
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: Up to 8 years from VY-AADC01 administration
Long-term safety of VY-AADC01 as measured by Adverse Events and Serious Adverse Events
次要结局
- Changes in PD medications(Up to 8 years from VY-AADC01 administration)
- Changes in "Off" and "On" time as recorded by the participant in Parkinson's Disease (PD) diary(Up to 8 years from VY-AADC01 administration)
- Change in AADC enzyme activity(Up to 8 years from VY-AADC01 administration)
- Changes in motor function as assessed by Unified Parkinson's Disease Rating Scale (UPDRS)(Up to 8 years from VY-AADC01 administration)
研究者
研究点 (3)
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