Multicentric randomized placebo controlled trial of Lithium carbonate combined with Riluzole in patients with ALS - RCT ALS Lithium

ISTITUTO SUPERIORE DI SANITA`0 个研究点开始时间: 2008年12月11日最近更新: 2012年3月19日

试验速览

暂无简介。

•1. Probable, probable-laboratory supported or definite ALS according to the revised version of the El Escorial World Fed. Neurology criteria with disease duration ≥ 6 and ≤ 36 months 2. Age ≥18 years and ≤ 75 years 3. Capable of understanding the information given and giving full informed consent 4.Continuously treated with Riluzole for at least 30 days and stabilized at 100 mg/day ( 50 mg bid) without significant drug reactions 5. FVC ≥ 60% of predicted 6. Female with child bearing potential, the patients must use adequate contraceptive measures and must not be pregnant or breastfeeding 7. Creatinine ≤ 1.5 mg/dl
•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

•1. Presence of a medical condition contra-indicative to the use of Lithium or known hypersensitivity to the study drugs 2. Patients already taking Lithium in any form 3. Participation in other therapeutic study within the preceding 30 days or use of other investigational drugs or agents 4.Presence the following medical conditions: a. assumption of abuse drugs; renal insufficiency, hepatic insufficiency, heart disease, endocrine or hematological disorders; infective diseases including HIV; cancer; b. evidence of major psychiatric disorders or clinically evident dementia; c. plasmatic TSH > 20% with respect to normal values; d. use of diuretics 5. Abnormal ECG 6. Any medical conditions known to have an association with other neurological systems 7 Tracheostomy or assisted ventilation of any type during the preceding 3 months

发起方