EUCTR2005-005873-31-IT进行中（未招募）不适用
A randomized, double-blind pilot study vs placebo for the evaluation of efficacy and tolerability of Erytropoietin administered by iv route as add-on treatment in patients affected by Amyotrophic Lateral Sclerosis ALS - ND
ISTITUTO NEUROLOGICO CARLO BESTA0 个研究点目标入组 20 人开始时间: 2006年3月14日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Caucasian male or female outpatients - aged 18 to 75 years inclusive - diagnosis of probable or definite ALS according to the El Escorial revised criteria Brooks et al., 2000 - first symptoms of ALS by no more than 2 years - in treatment with steady regimen of Riluzole and Vitamin E by at least 3 months, and desiring its continuation - FVC 75 of predicted - no conditions known to be contraindications to the use of EPO -written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- subjects who underwent tracheostomy - subjects with signs of conduction blocks of motor nerves, sensory nerves or both on nerve conduction study - subjects with clinical signs of dementia - history of myocardial infarction or thrombotic vascular events such as stroke, pulmonary emboli, deep vein thrombosis, TIA - clinically evident cardiac disease ischemic heart disease or congestive heart failure - uncontrolled hypertension - active malignancy - polycytemia - myeloproloferative disorders - hypercoagulabily disorders - porphyria - known hypersensitivity to human albumin - pregnant and lactating women - subjects who received an experimental drug or have participated in a clinical trial within 3 months prior to screening - employees of the Investigator or study centre with direct involvement in the study or in other sudies under the direction of the Investgator or study center
研究者
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