NCT07279844尚未招募不适用
An Open-label, Observational, Long-term Follow-up Study Evaluating the Safety and Efficacy of RGL-193 Putamen Injection in Patients With Primary Parkinson's Disease
Anhui Provincial Hospital0 个研究点目标入组 6 人开始时间: 2025年12月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
- 主要终点
- To evaluate the long-term safety of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years
研究概览
简要总结
To evaluate the long-term safety of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years
详细描述
An open-label, observational, long-term follow-up study evaluating the safety and efficacy of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have previously participated in RGL-193-related studies and have received RGL-193 treatment；
- •Those who voluntarily participate in this trial and sign a written informed consent form -
排除标准
- 未提供
结局指标
主要结局
To evaluate the long-term safety of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years
时间窗: 52 weeks after core-shell injection
次要结局
- Assess the metabolic activity of related enzymes in patients with primary PD over 5 years following RGL-193 capsid injection.(52 weeks after core-shell injection)
研究者
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