A double blind, placebo controlled, parallel groups, multicenter study on filgrastim in amyotrophic lateral sclerosis - STEMALS-II

niversità degli Studi di Torino e Azienda Ospedaliera Città della Salute e della Scienza di Torino0 个研究点目标入组 90 人开始时间: 2014年6月12日最近更新: 2020年11月30日

研究概览

暂无简介。

•a. patients with definite, probable, probable laboratory-supported or possible ALS
•b. age 20-75 years;
•c. disease duration <=24 months;
•d. respiratory function (FVC) = 65% of expected;
•e. patients must understand and accept the protocol requirements, and must give a 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 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

•a. previous polio infection ;
•b. motor neuron diseases other than ALS (progressive bulbar palsy , progressive muscular atrophy , primary lateral sclerosis );
•c. clinical involvement of other neurological systems (sensory, extrapyramidal , oculomotor, cerebellar);
•d. serious clinical conditions such as cardiovascular disease, uncontrolled hypertension, renal or hepatic impairment , dysthyroidism , Respiratory Distress Syndrome (ARDS) , sickle-cell anaemia;
•e. subjects who have participated in any drug trial within 12 weeks prior to recruitment;
•f . concomitant malignancy, present or past, with the exception of different melanoma skin cancers and carcinoma in situ of the cervix;
•g . patients with severe congenital neutropaenia syndrome with abnormal cytogenetics;
•h . patients with rare hereditary problems of fructose intolerance;
•i . present or past malignant myeloproliferative diseases, secondary polycythemia, splenomegaly with a diameter> 14 cm, thrombophilia was found;
•j . presence of percutaneous gastrostomy at the time of recruitment ;
•k . presence of NIV at the time of recruitment;
•l. subjects who have participated in any drug trial within 12 weeks prior to recruitment;
•n . drug addiction , alcoholism, or psychiatric disorders;
•o . women who are pregnant or breastfeeding.

发起方

niversità degli Studi di Torino e Azienda Ospedaliera Città della Salute e della Scienza di Torino