NCT01384162终止1 期
An Open Label, Safety and Tolerability Continuation Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis, Using an Implanted Catheter and SynchroMed® II Pump
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety and tolerability through assessments of adverse events, vital signs, clinical laboratory tests, MRI of brain, fundus photography and device performance as characterized by catheter tip placement and infusion accuracy
研究概览
简要总结
This is an open label safety and tolerability continuation study of intracerebroventricular administration of sNN0029, containing the growth factor VEGF165, in patients with amyotrophic lateral sclerosis that have previously participated in study sNN0029-001. The intention of the study is to investigate safety and tolerability of intracerebroventricular administration of sNN0029 and whether it can improve motor function and prolong survival in patients with ALS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ALS classified as definite, or probable with or without additional laboratory evidence, according to the revised WFN El Escorial criteria (Appendix B).
- •Previous participation in study sNN0029-001 with completion of 12 weeks study drug administration.
- •To have completed the investigations associated with safety in study sNN0029-001 without development of clinically significant safety concerns.
- •Patient has been given written and verbal information about the continuation study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments.
- •Patient has given oral and / or signed consent (written) to participate in the study. In the event that a patient who gives oral informed consent is not physically able to sign the informed consent form (ICF) due to disease progression, a witness may sign the ICF on the patient's behalf.
排除标准
- •Hypertension defined as blood pressure >160 mmHg systolic or >90 mmHg diastolic.
- •Proliferative retinopathy.
- •Non-proliferative retinopathy of moderate severity or higher.
- •Concurrent clinically significant dementia as determined by the investigator.
- •Concurrent clinically significant depression as determined by the investigator.
- •Need for administration of any antiplatelet or anticoagulant medication (e.g. aspirin, Plavix, non-steroidal anti-inflammatory drugs [NSAIDs]). Low dose aspirin or occasional use of NSAIDs is allowed (See Appendix E).
- •Clinically significant abnormalities in haematology or clinical chemistry parameters as assessed by the investigator.
- •For female patients, ongoing pregnancy or planned pregnancy
- •Breast feeding
研究组 & 干预措施
sNN0029, ICV infusion
Experimental
干预措施: sNN0029 (Drug)
结局指标
主要结局
Safety and tolerability through assessments of adverse events, vital signs, clinical laboratory tests, MRI of brain, fundus photography and device performance as characterized by catheter tip placement and infusion accuracy
时间窗: multiple assessments over 120 weeks
次要结局
- Disease activity as measured by ALS functional rating scale (FRS) - VEGF concentrations in CSF - Possible VEGF antibodies in plasma(Multiple assessments over 120 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)Amyotrophic Lateral SclerosisNCT00931944Knopp Biosciences74
已完成
3 期
Long Term Safety Study of PlecanatideIrritable Bowel SyndromeNCT02706483Bausch Health Americas, Inc.2,272
终止
2 期
Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074Neuropathic Pain From Lumbosacral RadiculopathyNCT02957617Biogen302
已完成
3 期
Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile DysfunctionErectile DysfunctionNCT00853606VIVUS LLC712
Unknown
1 期
Safety and TDM of Continuous Infusion Vancomycin Through Continuous Renal Replacement Therapy SolutionPediatric Continuous Renal Replacement TherapyDialysisRenal FailureNCT02663596Drexel University10