2025-522653-19-00招募中4 期
(ASK-PD0-CS002) Long-Term Safety and Efficacy Follow-up of AB-1005 Gene Transfer Study Participants with Parkinson’s Disease or Multiple System Atrophy
Askbio Inc., AskBio France2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月22日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence and severity of AEs (serious and non-serious)
研究概览
简要总结
To evaluate the long-term safety and tolerability of AB-1005 in participants with Parkinson's Disease (PD) or Multiple System Atrophy-Parkinsonian subtype (MSA-P)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •PD and MSA-P participants that are or were enrolled in an interventional AB-1005 study and provide informed consent.
排除标准
- •There are no exclusion criteria for this study
结局指标
主要结局
Incidence and severity of AEs (serious and non-serious)
Incidence and severity of AEs (serious and non-serious)
次要结局
- For PD participants - Normalized PD motor diary times (Good ON, ON with troublesome dyskinesia, OFF)
- For PD participants - MDS-UPDRS part III (OFF and ON)
- For PD participants - MDS-UPDRS part II (OFF and ON)
- For PD participants - MDS-UPDRS part I
- For PD participants - MDS-UPDRS part IV
- For PD participants - Levodopa equivalent daily dose (LEDD)
- For PD participants - 18F-DOPA PET
- For MSA participants - UMSARS parts I, II (ON), III, IV
- For MSA participants - MSA-QoL
研究者
Yiqun (Ellie) Hu, M.D., Ph.D.
Scientific
Askbio Inc.
研究点 (2)
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