ALS patient according with the El-Escorial criteria MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Conditions
Interventions
Trade Name: CARBOLITHIUM*100CPS 150MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Lithium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a)Diagnosis of clinically definitive, probable or probabile laboratory-supported, possible ALS b)Adult males and females aged 18 to 75 years. c)Onset of disease within 36 months. d)Value more than 2 at the point Swallowing in the ALS-FRS-R scale, value more than 2 at the point walking in the ALS-FRS-R scale, value more than 3 at the point respiratory function at the ALS-FRS- R scale e)Progression of disease in the last 3 months. f)Able to understand the protocol and to give written informed consent. g)Concomitant standard Riluzole therapy 50 mg twice daily for at least 2 months or without standard Riluzole therapy during the period of the study. 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.pregresse poliomielite b.other motoneuron diseases different from ALS (progressive bulbar paralysis, progressive muscular atrophy, primary lateral sclerosis) c. other neurological diseases (sensory, extrapiramidal, cerebellar) d.A clinical relevant presence of cardiovascular, arterious hypertension, renal, hepatic and endocrine diseases. e.Creatininemie> 1,6 mg/dl f.A clinical relevant medical history of cardiovascular, brain vascular diseases. g.A history of presence of malignancy h.Important cognitive disorders i.Low compliance in past therapy j.Female with intention of pregnancy or breast feeding . the non-pregnancy will confirmed by pregnancy test a week before the onset of treatment. The absence of pregnancy risk is indicated by (1) menopause state, (2) total hysterectomy, (3) adequate method of contraception, (4) sexual inactivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the impact of Litio with a level between 0,4 and 0,8 mEq/L per os for 15 months on the disability of the ALS;Secondary Objective: Evaluation of the drug tolerability and safety;Primary end point(s): Death or tracheostomy, or almoust 2 of the 3 following value at the ALS-FRS-R: 1 at the point swallowing, 1 at the point walking, 2 at the point respiratory failure. | — |
Countries
Italy
Outcome results
None listed