Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 71
- 主要终点
- Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery
研究概览
简要总结
The purpose of the study is to explore the safety, tolerability and efficacy of Spheramine (cultured human retinal pigment epithelial cells on microcarriers) in Parkinson's Disease patients with advanced disease who have insufficient symptom control by optimum oral medication. Patients are randomized to receive Spheramine injections into both hemispheres or a sham surgical procedure in a ratio of 1:1. A three month pretreatment period must be completed prior to surgery. Time to endpoint is 24 months.
详细描述
This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced Parkinson's disease for at least 5 years
- •Good response to L-dopa
- •Age 30 to 70 years
- •Optimum oral therapy
排除标准
- •Tremor only
- •Very severe dyskinesia
- •Previous brain surgery including deep brain stimulation
- •Malignant disease
研究组 & 干预措施
Arm 1
干预措施: Spheramine (BAY86-5280) (Biological)
Arm 2
干预措施: Placebo (Procedure)
结局指标
主要结局
Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery
时间窗: 12 months post surgery
次要结局
- Change in total UPDRS in ON and OFF at 12 months post surgery(12 months post surgery)
- Change in UPDRS Part III in ON at 12 months post surgery(12 months post surgery)
- Amount of L-dopa reduction at 12 months post surgery(12 months post surgery)
- Activities of Daily Living subscore of the UPDRS at 12 months post surgery(12 months post surgery)
- Percent time spent in ON and OFF at 12 months post surgery(12 months post surgery)
- Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery(12 months post surgery)