Amyotrophic Lateral Sclerosis MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Conditions
Sponsors
ISTITUTO SUPERIORE DI SANITA`
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Probable, probable-laboratory supported or definite ALS according to the revised version of the El Escorial World Fed. Neurology criteria with disease duration ≥ 6 and ≤ 36 months 2. Age ≥18 years and ≤ 75 years 3. Capable of understanding the information given and giving full informed consent 4.Continuously treated with Riluzole for at least 30 days and stabilized at 100 mg/day ( 50 mg bid) without significant drug reactions 5. FVC ≥ 60% of predicted 6. Female with child bearing potential, the patients must use adequate contraceptive measures and must not be pregnant or breastfeeding 7. Creatinine ≤ 1.5 mg/dl 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: 1. Presence of a medical condition contra-indicative to the use of Lithium or known hypersensitivity to the study drugs 2. Patients already taking Lithium in any form 3. Participation in other therapeutic study within the preceding 30 days or use of other investigational drugs or agents 4.Presence the following medical conditions: a. assumption of abuse drugs; renal insufficiency, hepatic insufficiency, heart disease, endocrine or hematological disorders; infective diseases including HIV; cancer; b. evidence of major psychiatric disorders or clinically evident dementia; c. plasmatic TSH > 20% with respect to normal values; d. use of diuretics 5. Abnormal ECG 6. Any medical conditions known to have an association with other neurological systems 7 Tracheostomy or assisted ventilation of any type during the preceding 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety and efficacy evaluation of Lithium carbonate combined with Riluzole in ALS. Primary endpoint is patient survival at month 18.;Secondary Objective: Evaluation of necessity of PAV or tracheostomy and measure of the rate of functional deterioration over 18 month measured by change in the slope of ALSFRS-R, FVC, MRC an McGill quality of life. Evaluation of safety of the treatment in patiens with ALS;Primary end point(s): Patient`s survival in the two groups at 18 months | — |
Countries
Italy
Outcome results
None listed