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Lithium trial in ALS


- candidate number3884
- NTR NumberNTR1448
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-aug-2008
- Secondary IDs08-192 METC UMC Utrecht
- Public TitleLithium trial in ALS
- Scientific TitleA randomised sequential trial of Lithium In amyotrophic lateral sclerosis
- ACRONYMLITRA
- hypothesisLithium 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.
- Healt Condition(s) or Problem(s) studiedAmyotrophic Lateral Sclerosis (ALS), Lithium
- Inclusion criteria1. 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%) ˇÝ 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2008
- planned closingdate30-sep-2010
- Target number of participants191
- InterventionsALS 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.
- Primary outcomeSurvival:
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 outcome- 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.
- TimepointsSequential analysis
- Trial web sitehttp://www.juliuscenter.com/LITRA
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIEStrial nurse I. Beilen, van
- CONTACT for SCIENTIFIC QUERIESDrs. E. Verstraete
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryAmyotrophic 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.
- Main changes (audit trail)
- RECORD28-aug-2008 - 19-jun-2011


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