NCT01856439终止1 期
A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.
Axovant Sciences Ltd.2 个研究点 分布在 2 个国家目标入组 15 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- To assess the long term safety and tolerability of ProSavin
研究概览
简要总结
The study is designed to assess the long term tolerability of ProSavin and whether it is safe and efficacious in patients administered ProSavin from the PS1/001/07 study .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have met all inclusion criteria for study PS1/001/07
- •willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.
- •affiliated with the French social security health care system (Patients enrolled in France only)
- •signed and dated written informed consent obtained from the patient and/or the patient's legally acceptable representative, if applicable, in accordance with the local regulations
- •must have been treated with ProSavin/Sham
排除标准
- 未提供
研究组 & 干预措施
Long term follow up
Other
Long term follow up of patient's who received ProSavin in previous study
干预措施: ProSavin (Drug)
结局指标
主要结局
To assess the long term safety and tolerability of ProSavin
时间窗: 10 years
The number and severity of any adverse event
次要结局
- Patients' responses to ProSavin administration(10 years)
研究者
研究点 (2)
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