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: 2012年3月19日

试验速览

暂无简介。

•- 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

•- 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

发起方

ISTITUTO NEUROLOGICO CARLO BESTA