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

niversitair Medisch Centrum Utrecht0 个研究点目标入组 191 人开始时间: 待定最近更新: 2024年5月13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.

•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.
•*Renal failure. Severe cardiac diseases. Brain damage. Addison disease. Hypothyroidism unresponsive to thyroid hormone suppletion. Precaution in patients with a (possibly) disturbed sodiumbalance like in extreme perspiration and sodium depleted diet.

发起方

niversitair Medisch Centrum Utrecht