Phase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- safety assessment measured by the absence of adverse events
研究概览
简要总结
The purpose of this study is to determine whether recombinant human Erythropoietin (EPOrh) is safe in the treatment of patients with Parkinson's Disease.
详细描述
After onset of Parkinson's Disease (PD)- in spite of the use of medications that constitute the symptomatic treatment- the disease is worsens with an inevitable progression, thus causing complications that lead to the loss of patient´s manual skills and independent gait. At present, the treatment of PD with the use of medications is based on dopamine precursors and dopaminergic agonists but as the disease advances, other symptoms that do not respond to dopaminergic stimulation do appear.
For this reason, it is a priority to find a way to focus on neuroprotection during the course of the disease. There are evidences of neuroprotecting therapeutic alternatives in such substances as erythropoietin (EPO).
Positive results on the neuroprotective/neurotrophic efficacy of EPO in neurological and psychiatric diseases have been obtained from treatment trials, but nevertheless, it is indispensable demonstrate that with the proposed medication doses it's well tolerated by PD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hohen and Yahr´s Scale between I and III
- •One or more years of evolution of PD,
- •Good response to levodopa (more that 30 % of change)valued in motor UPDRS
- •An acceptable general health status,
排除标准
- •Chronic psychiatric or other neurological diseases.
- •Previous polyglobulin
- •Hematocryte, same or inferior to 50
研究组 & 干预措施
Erythropoietin
There are evidences of neuroprotecting therapeutic alternatives in such substances as erythropoietin (EPO) which is a well-known cytokine as a hematopoietic growth factor, so, it is therefore important to control tissular oxygenation. It is considered that EPO protects the neurons by a combination of several mechanisms.
EPOrh is used with high effectiveness in the treatment of anemias with deficiency of erythropoietin.
干预措施: Erythropoietin human recombinant (EPOrh) (Drug)
结局指标
主要结局
safety assessment measured by the absence of adverse events
时间窗: weeks 1 to 5, 6, 12, 23 and 35
次要结局
- Post-treatment change in the motor score of the Unified Assessment Scale for Parkinson Disease´s (UPDRS) in the "OFF" condition as compared with the baseline.(week 6, 12, 23 and 35)
研究者
Ivonne Pedroso Ibanez
Head of the Movement Disorders Clinic
International Center for Neurological Restoration, Cuba