A randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALS

Prof. dr L.H. van den Berg, UMC-Utrecht0 个研究点开始时间: 2008年8月5日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Definite, probable, or probable-laboratory supported ALS according to the revised El Escorial World Federation of Neurology criteria.
•2. Intake of riluzole 2dd 50 mg
•3. A disease duration (at inclusion) of more than 6 months and less than 36 months (disease onset is defined as the date of first symptoms excluding muscle cramps and fasciculations)
•4. Vital capacity (VC%) = 70 % of normal value
•(slow expiration, best of a minimum of three and a maximum of five measurements, with a respiratory function validly assessable and spontaneous, non-assisted ventilation)
•5. Age 18 - 85 years (inclusive)
•6. Capable of thoroughly understanding the trial information given; has signed the 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

•1. Tracheostomy, tracheostomal ventilation of any type, non-invasive ventilation more than 16 hours/ day, or supplemental oxygen during the last three months prior to inclusion.
•2. Any medical condition or intoxication known to have an association with motor neuron dysfunction, which might confound or obscure the diagnosis of ALS.
•3. Presence of any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment.
•4. Contra-indications for lithium therapy
•5. Interaction of lithium with other medication (like NSAID’s and thiazide diuretics) that increase the chance of intoxication.

发起方

Prof. dr L.H. van den Berg, UMC-Utrecht