Evaluation of efficacy of lithium salts therapy in patients with Amyotrophic Lateral Sclerosis. - ND

Conditions: Amyotrophic Lateral Sclerosis
MedDRA version: 9.1Level: LLTClassification code 10002026Term: Amyotrophic lateral sclerosis

Registration Number: EUCTR2009-010060-41-IT

Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures