Lithium treatment potentially enhances survival and slows disease progression in ALS patients
ID
Source
Brief title
Health condition
ALS amyotrophic lateral sclerosis amyotrofische laterale sclerose
Sponsors and support
Dep. neurology, UMC-Utrecht
Heidelberglaan 100/HP G03.228
3584CX Utrecht
Tel: +31-88-7557939
Fax: +31-30-2542100
Email: L.H.vandenBerg@umcutrecht.nl
Loolaan 31a
7314 AB Apeldoorn
Tel. 055-5266 500
Fax. 055-5266 501
Intervention
Outcome measures
Primary outcome
- Survival
Secondary outcome
- The rate of decline in daily functioning
Study objective
Lithium treatment potentially enhances survival and slows disease progression in ALS patients
Study design
Sequential analyses of the data.
Visits at t=3, 6 and 12 months.
Intervention
Lithium carbonate (plasma levels between 0,4-0,8mmol/l) vs. placebo
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
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
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
4. Vital capacity (VC%) ¡Ý 70 % of normal value
5. Age 18 - 85 years
6. Capable of thoroughly understanding the trial information given; has signed the informed consent.
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1372 |
| NTR-old | NTR1432 |
| Other | UMC Utrecht : LTA-2-2008 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
| CCMO | NL22827.041.08 |
| OMON | NL-OMON31977 |