Amyotrophic Lateral Sclerosis MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Conditions
Interventions
Trade Name: LITIO CARBONATO
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lithium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: RILUTE
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. definite, probable or probable with laboratory support ALS; b. age >18 yrs; c. disease duration less then 36 months; d. treatment with Riluzole and vitamin E (400 mg/day) for 30 days every three months; e. mild or moderate disability; f. capacity to understand and to do their consensus to the study; g. negativity of the pregnancy 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. psychiatric diseases (Axis 1 o 2 del DSM IV); b. mental impairment; (QI alla WAIS < di 45); c.hypothyroidism; d. pharmacologic treatment incompatible with lithium; e. allergy or hyper-sensibility to lithium; f. heart disease and/or renal impairment; g. diuretic treatment; h. epilepsy; i. motor neuron disease different from ALS; j. other neurological diseases; k. scarce compliance; l. PEG or tracheotomy. m. pregnancy and feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the lithium salts efficacy on disease progression.;Secondary Objective: Evaluation of drug safety.;Primary end point(s): 1) survival evaluation without complications; 2) survival evaluation with complications (PEG or tracheotomy). | — |
Countries
Italy
Outcome results
None listed