DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL ON THE USE OF ACETYL-L-CARNITINE FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)

INTERVENTION: Trade Name: ZIBREN*20BUST 500MG Pharmaceutical Form: Oral powder INN or Proposed INN: Acetylcarnitine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ CONDITION: Amyotrophic lateral sclerosis therapy ; MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis PRIMARY OUTCOME: Main Objective: Assessment of the impact of LAC at the dose of 3g/day by oral route for 12 consecutive months on the disability of ALS, in a clinically significant and measurable way Primary end point(s): The primary end‐point is the proportion of cases becoming non‐self supporting during the 12‐month follow‐up period. Secondary Objective: 1)Assessment of the impact of the drug on mortality (all causes); 2)Evaluation of the tolerability and safety of the drug at the given treatment regimen. INCLUSION CRITERIA: Inclusion criteria To be accepted, a case must satisfy all of the following: a. Diagnosis of definite, probable (laboratory‐supported) or probable ALS (Sect. 5); b. Age between 40 and 70 years; c. Disease duration 6 < months < 24 months; d. Mild to moderate disability, documented by satisfactory bulbar and spinal function (minimal score of 3 on ALS Functional Rating Scale [ALS‐FRS‐R] 34 for swallowing, cutting food and handling utensils, and walking), satisfactory respiratory function (forced vital capacity (FVC) > 80% of predicted); e. Documented progression of the disease in the last 3 months; f. Patients able to understand, to comply with the requirements of the entire study, and to give an informed written 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 thi