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Lithium trial bij ALS


- candidate number3924
- NTR NumberNTR1432
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-sep-2008
- Secondary IDsLTA-2-2008 UMC Utrecht
- Public TitleLithium trial bij ALS
- Scientific TitleA randomised sequential trial of Lithium in amyotrophic lateral sclerosis
- ACRONYMN/A
- hypothesisLithium treatment potentially enhances survival and slows disease progression in 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
4. Vital capacity (VC%) 70 % of normal value
5. Age 18 - 85 years
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
- mec approval receivedno
- 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
- InterventionsLithium carbonate (plasma levels between 0,4-0,8mmol/l) vs. placebo
- Primary outcome- Survival
- Secondary outcome- The rate of decline in daily functioning
- TimepointsSequential analyses of the data.
Visits at t=3, 6 and 12 months.
- Trial web siteN/A
- statusplanned
- 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)
Stichting ALS Nederland
- PublicationsN/A
- Brief summary
- Main changes (audit trail)
- RECORD5-sep-2008 - 16-sep-2008


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