NCT01807338已完成不适用
A Follow-up Study on Safety and Tolerability and Pharmacodynamic Effect, of Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Who Have Previously Been Treated With sNN0031, Using an Implanted Catheter and a SynchroMed® II Pump
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of this study is to document the long-term safety and tolerability after intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who participated in study sNN0031-001
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous participation in study sNN0031-001 with completion of 12 study weeks without development of clinically significant safety concerns, defined as being any drug-related or device related serious adverse event that resulted in premature termination of treatment or a medical device incident that could not be resolved during the conduct of study sNN0031-001
- •The patient has a diagnosis of idiopathic PD
- •The patient has been given written and verbal information about the follow-up study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments
- •The patient has provided written informed consent to participate in the follow-up study
排除标准
- •The patient has been included or participates in another clinical study after participation in Study sNN0031-001
- •The patient has, since participation in study sNN0031-001, had functional neurosurgical treatment for PD (e.g., deep brain stimulation).
- •Patients will only be excluded from participation in the event of a laboratory test abnormality that is indicative of a medical condition requiring treatment which, in the opinion of the investigator, is not compatible with participation in the present study
结局指标
主要结局
Number of participants with adverse events
时间窗: up to 3 years
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 TrialHIV InfectionsNCT00622232VIRxSYS Corporation40
已完成
不适用
Long-term Safety Follow-up Study of Patients Having Received HepaStem (SAF001)Urea Cycle DisordersCrigler Najjar SyndromeNCT02051049Cellaion SA9
已完成
3 期
Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HFHeart FailureNCT03785405Novartis Pharmaceuticals216
已完成
不适用
Long-term Follow-up for Evaluating the Safety of CS20AT04 in Subject with Lupus NephritisLupus NephritisNCT04522505Corestemchemon, Inc.6
Enrolling By Invitation
2 期
Long-term Follow-Up Study of RGX-314 and Fellow Eye SubstudyNeovascular Age-related Macular DegenerationWet Macular DegenerationNCT03999801AbbVie865