Amyotrophic lateral sclerosis therapy MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Conditions
Interventions
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-
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria The presence of at least one of the following leads to exclusion of the patient: a. Familial ALS; b. Antecedent polio infection; c. Motor neuron disease other than ALS (progressive bulbar palsy; progressive muscular atrophy; primary lateral sclerosis); d. Involvement of other neurological systems (sensory, extra pyramidal, oculomotor, cerebellar, autonomic). e. Antecedent or current exposure to metals (lead, aluminium, mercury, manganese, magnesium, selenium); f. Diabetes, severe clinical conditions, like cardiovascular disorders, arterial hypertension, kidney and liver disorders, dysthyroidism; g. Neoplasms or other diseases reducing life expectancy; h. Severe mental deterioration; i. Poor compliance with previous treatments; l. Neuroradiologic findings documenting lesions which might be responsible of the clinical findings; m. Experimental treatments in the preceding 3 months; n. Women who are pregnant or breast-feeding and/or of childbearing potential for the duration of the study; o. Patient and/or caring physician unwilling to take and/or prescribe riluzole.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Primary end point(s): The primary end-point is the proportion of cases becoming non-self supporting during the 12-month follow-up period.;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 | — |
Countries
Italy
Outcome results
None listed