Lithium has important neuroprotective properties involving mechanisms that may play a role in the pathogenesis of ALS. In addition, lithium significantly prolonged the disease duration in the animal model for ALS, the SOD1 transgenic mouse as also…
ID
Bron
Verkorte titel
Aandoening
amyotrophic lateral sclerosis
amyotrofe laterale sclerose
ALS
lithium
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Survival:<br>
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.
Achtergrond van het onderzoek
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease with loss of motor neurons in the brain and spinal cord. A recent study has suggested a favourable effect of lithiumcarbonate on survival and disease progression. We'll perform a randomised sequential trial of Lithiumcarbonate versus placebo in ALS. Survival is the primary outcome measure and daily functioning is a secondary outcome measure.
Doel van het onderzoek
Lithium has important neuroprotective properties involving mechanisms that may play a role in the pathogenesis of ALS. In addition, lithium significantly prolonged the disease duration in the animal model for ALS, the SOD1 transgenic mouse as also in a small cohort of ALS patients.
Onderzoeksopzet
Sequential analysis
Onderzoeksproduct en/of interventie
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 reached.
Algemeen / deelnemers
Department of Neurology<br>
HP C03.236
I. Beilen, van
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88 7553204
I.R.A.vanBeilen@umcutrecht.nl
Wetenschappers
Department of Neurology<br>
HP C03.236
I. Beilen, van
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88 7553204
I.R.A.vanBeilen@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1388 |
NTR-old | NTR1448 |
Ander register | METC UMC Utrecht : 08-192 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |