EUCTR2017-005170-19-SE进行中（未招募）1 期
A Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients who completed Visit 4, implantation of the DDS, in the main study (HP-CD-CL-2002).
- •2. Patients that fulfil any of the following criteria:
- •a. Discontinued the main study (HP-CD-CL-2002) after Visit 4, or, the extension study (HP-CD-CL-2003), or,
- •b. Completed the main study (HP-CD-CL-2002) having received 6 doses of treatment, but did not continue in the extension study (HP-CD-CL-2003), or,
- •c. Patients that completed also the extension study, receiving a total of 12 doses of treatment (HP-CD-CL-2003).
- •3. Provision of informed consent. The patient is judged by the investigator to be alert and oriented to person, place, time and situation when giving the informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- 未提供
研究者
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