A randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALS

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-002110-22-NL
• Date of registration: 05/08/2008
• Prospective Registration: Yes
• Primary sponsor: Prof. dr L.H. van den Berg, UMC-Utrecht
• Public title: A randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALS
• Scientific title: A randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALS
• Date of first enrolment: 16/09/2008
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002110-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Netherlands

Key inclusion & exclusion 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%) = 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Amyotrophic lateral sclerosis (ALS) is a disease characterised by progressive degeneration of motor neurons in brain and spinal cord leading to muscle weakness. ALS can occur at anytime in adulthood. Muscle weakness gradually progresses. Approximately 50% of patients die within 3 years after onset of symptoms, usually as the result of respiratory failure. To date, only one drug, i.e. riluzole, has proven to extend survival in patients with ALS, but only by approximately 3 to 6 months.
MedDRA version: 9.1 Level: LLT Classification code 10052889 Term: ALS

Intervention(s)

Trade Name: Lithiumcarbonaat 400 PCH tabletten
Product Name: Lithiumcarbonaat
Pharmaceutical Form: Tablet
CAS Number: 554132
Other descriptive name: LITHIUM CARBONATE
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 400-400
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To determine the effect of lithium treatment (plasma levels between 0,4-0,8 mEq/liter) versus placebo - in addition to riluzole 2dd 50 mg - on reaching a clinical endpoint in patients with ALS.

Secondary Objective: Investigate the rate of decline in daily functioning of ALS patients treated with lithium versus placebo.
Get insight in the adverse effects and reactions due to lithium treatment compared to placebo in ALS patients.
Gain insight in the working mechanism of lithium.

Primary end point(s): Primary outcome measure: 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 ID(s)

LTA-2-2008