NCT01586052已完成1 期
A Phase 1 Clinical Research of Erythropoietin Therapy for Children With Cerebral Palsy: Safety and Efficacy
MinYoung Kim, M.D.1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This purpose of this phase 1 study is to investigate the safety and efficacy of erythropoetin for children with cerebral palsy.
详细描述
Cerebral palsy is a disorder of movement and posture resulted from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.
Many experimental animal studies have revealed that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed as follows; neuroprotection effect, angiogenesis, and anti-inflammation.
On the basis of many experimental studies, erythropoietin is suggested as a potential therapy for cerebral palsy.
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
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral Palsy
- •Abnormal Muscle Tone
- •GMFCS (Gross Motor Functional Classification System): II to IV
- •Age: 6 months ~ 3 years
- •Abnormal Brain MRI compatible to clinical features and non-progressive
- •Willing to Comply with All Study Procedure
排除标准
- •Known Genetic Disorder
- •Baseline Erythropoietin level > 45 mU/mL
- •Presence of Drug Hypersensitivity Related to the Study Remedy
- •Previous Erythropoietin Treatment before 3 months
- •Coagulopathy:
- •Family History, Unknown Cerebral Infarction, Thromboembolic Events History
- •Intractable Seizure Disorder
- •Poor Cooperation of Guardian including Inactive Attitude for Rehabilitation
- •Uncontrolled Hypertension
- •Liver Dysfunction
- •Renal Dysfunction
- •Absolute Neutrophil Count < 500/dL
- •Intracerebral or Intraventricular Hemorrhage
- •Malignancy
研究组 & 干预措施
Erythropoietin and Rehabilitation
Experimental
recombinant human erythropoietin injection and active rehabilitation
干预措施: Erythropoietin (Drug)
结局指标
主要结局
Adverse Events
时间窗: 8 weeks
Monitoring of all adverse events during 8 weeks, the study period We selected specially considered adverse events: encephalopathy, intracranial hemorrhage, seizure, hypertension, thromboembolic event, hypoxia, and acute kidney injury. Other adverse events will be recorded. The list was determined by the clinical experience and all adverse reactions reported by the pharmaceutical company.
次要结局
- Changes in Quality of Movement(Baseline - 8 weeks)
- Changes in Gross Motor Function(Baseline - 8 weeks)
- Changes in Neurodevelopmental Outcomes(Baseline - 8 weeks)
- Changes in Motor Development(Baseline - 8 weeks)
- Changes in Spasticity(Baseline - 8 weeks)
研究者
MinYoung Kim, M.D.
Associate Professor
Bundang CHA Hospital
研究点 (1)
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