A Double-Blind, Placebo-Control, Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Motor Performance of Unified Parkinson's Disease Rating Scale
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of neuroprotection from granulocyte colony-stimulating factor on Parkinson disease
详细描述
Parkinson's disease (PD) is the second most common neurodegenerative disease and the severity of PD still progress during the ensuing years. Currently, there is no promising medical or surgical treatment to abrogate the disease deterioration. Granulocyte colony-stimulating factor (G-CSF), one of hematopoietic growth factors, has been routinely used for hematologic disorders and stem cell harvest from normal subject. G-CSF also demonstrated neuroprotection for rodents PD model. We hypothesize G-CSF will exert the effectiveness of neuroprotection for PD patients.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hoehn & Yahr stage I~III
- •Patients with idiopathic Parkinson's disease(PD), who meet the United Kingdom Parkinson's Disease Society Brain Bank diagnostic criteria, with a good response to levodopa
- •The onset of PD symptoms must be occurred > = 40 years of age (to exclude YOPD), and the patient must have been diagnosed with idiopathic PD > =40 years of age
- •Patients may have symptoms of wearing OFF and/or levodopa induced dyskinesia
- •Patients must rate between Hoehn & Yahr stage I to III, when in an OFF medication state
- •Patients must in their optimal medication treatment state, and will not changing their medications within 3 months before and after enrollment
排除标准
- •Patients who are proved to be Young Onset Parkinson's Disease (YOPD) and/or genetically related (e.g. Parkin).
- •Women of child-bearing potential, pregnant or lactating.
- •Patients who are proved to have tumor growth and/or malignancy.
- •Patients with a past (within one year) or present history of psychotic symptoms requiring anti- psychotic treatment.
- •Patients with active symptoms of major depression with suicidal ideation or suicide attempt.
- •Patients with previous brain surgery (including pallidotomy and deep brain stimulation).
- •Patients with significant cognitive impairment ( Mini-Mental State Examination, MMSE < 24).
- •Patients who do not sign the inform consent,
研究组 & 干预措施
high dose G-CSF
high dose group: 3.3ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)
干预措施: G-CSF (Drug)
low dose G-CSF
low dose group: 1.65ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)
干预措施: G-CSF (Drug)
placebo
Sodium Chloride (NaCl) 0.9 %
干预措施: Placebo (Drug)
结局指标
主要结局
Motor Performance of Unified Parkinson's Disease Rating Scale
时间窗: 2 years
To assess Unified Parkinson's Disease Rating Scale part III (motor function) scores from baseline Medication-off status to Medication-off status after G-CSF injection one year. Scores of UPDRS Part III ranges from 0 to 108 and higher values indicate worse outcome.
次要结局
未报告次要终点