amyotrophic lateral sclerosis amyotrofe laterale sclerose ALS lithium
Conditions
Interventions
ALS patients included in the trial are treated with either Lithiumcarbonate (plasma level 0,4-0,8mmol/l) or placebo. The duration of follow-up is maximal 2 years or untill a clinical endpoint is reach
Sponsors
Prof.dr L.H. van den Berg, neurologist in the University Hospital of Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 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%) ¡Ý 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.
Exclusion criteria
Exclusion criteria: 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. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival: survival is defined as the time from inclusion to reaching a clinical endpoint. A clinical endpoint is reached when death, tracheostomy, permanent assisted ventilation (PAV) or non-invasive ventilation (NIV) for over 16 hours occurs. Permanent assisted ventilation is defined as intubation with artificial ventilation ultimately leading to tracheostomy or death. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The rate of decline in daily functioning: The “ALS Functional Rating Scale” (ALSFRS-R) is an easily applicable questionnaire, to assess the opinion of the patient regarding his/her own possibilities and/or dependency in the activities of daily living. The rate of decline of the ALSFRS-R will be measured from inclusion to the clinical endpoint. | — |
Contacts
Public ContactI. Beilen, van
UMC Utrecht Department of Neurology HP C03.236
Outcome results
None listed