Patients affected by amyotrophic lateral sclerosis (ALS) MedDRA version: 6.1 Level: PT Classification code 10002026
Conditions
Sponsors
I.N.M. NEUROMED (I.R.C.C.S.) S.R.L. GIA' SANATRIX
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A-als clinically defined, ALS clinically likely,or likely with instrumental support. B-age, over 18 years C-disease duration less than 36 months D-The patients must be already treated with riluzole, in association with vitamine E (400 mg/Kg) as an antioxidant (for 30 days every three months) E-slight or moderate neurological impairment, as documented by efficient bulbar or spinal function. This means for instance a score defined by ALS-FRS-R of at least 3 for bulbar(i.e. swallowing)/spinal functions; moreover thre breathing function must be acceptable. F-Patients must be able to understand and agree to the present research protocol and they must provide a signed informed consent. G-For fertile women, a potential pregnancy need to be ruled out by appropriate lab test. 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
Exclusion criteria: A-Patients with severe psychiatric disorders (as defined by DSM IV axis I or II) B-Patients with mental retardation severe or very severe. C-Patients affectd by clinically evident hypothiroidism D-Patients under medical therapies which cannot be administered in association with lithum. E-previously reported allergic reactions against lithium salts F-Patients affected by cardiovascular disorders and/or renal faliure. G-patients under diuretic therapy. H-epileptic patients I- Patients affected by motro neuron disorder s others then ALS. J-Presence of other neurological symptoms (sensitive, extrapyramidal, oculomotore, cerebellar, autonomic disorders). K- Previously reported loww compliance to drug therapies. L-Patients carrying PEG or tracheostomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO EVALUATE THE EFFICACY OF LITHIUM SALT TO SLOW DOWN THE PROGRESSION OF ALS;Secondary Objective: TO EVALUATE IN DETAIL: 1-INCREASE IN LIFE EXPECTANCY 2-DECREASE IN NEUROLOGICAL IMPAIRMENT 3-POTENTIAL BLOCKADE OF DISEASE PROGRESSION;Primary end point(s): 1-EVALUATION OF SURVIVAL WITHOUT COMPLICATIONS 2-EVALUATION OF SURVIVAL WITH COMPLICATIONS | — |
Countries
Italy
Outcome results
None listed