MULTICENTER TRIAL (SINGLE BLIND)VS ON THE EFFICACY OF LITHIUM SALTS +RILUZOLE VS PLACEBO+RILUZOLE IN PATIENTS AFFECTED BY AMYOTROPHIC LATERAL SCLEROSIS - EFFICACY OF LITHIUM IN ALS

• Register: EUCTR
• Last refreshed on: 17 February 2014
• Main ID: EUCTR2007-002379-16-IT
• Date of registration: 09/11/2007
• Prospective Registration: No
• Primary sponsor: I.N.M. NEUROMED (I.R.C.C.S.) S.R.L. GIA' SANATRIX
• Public title: MULTICENTER TRIAL (SINGLE BLIND)VS ON THE EFFICACY OF LITHIUM SALTS +RILUZOLE VS PLACEBO+RILUZOLE IN PATIENTS AFFECTED BY AMYOTROPHIC LATERAL SCLEROSIS - EFFICACY OF LITHIUM IN ALS
• Scientific title: MULTICENTER TRIAL (SINGLE BLIND)VS ON THE EFFICACY OF LITHIUM SALTS +RILUZOLE VS PLACEBO+RILUZOLE IN PATIENTS AFFECTED BY AMYOTROPHIC LATERAL SCLEROSIS - EFFICACY OF LITHIUM IN ALS
• Date of first enrolment: 29/05/2007
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002379-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: LO STUDIO PREVEDE IL CAMBIAMENTO IN APERTO OVE SI VERFICHI UNA DIFFERENZA > 50% TRA I DUE GRUPPI If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion criteria:
A-als clinically defined, ALS clinically likely,or likely with instrumental support. B-age, over 18 years C-disease duration less than 36 months D-The patients must be already treated with riluzole, in association with vitamine E (400 mg/Kg) as an antioxidant (for 30 days every three months) E-slight or moderate neurological impairment, as documented by efficient bulbar or spinal function. This means for instance a score defined by ALS-FRS-R of at least 3 for bulbar(i.e. swallowing)/spinal functions; moreover thre breathing function must be acceptable. F-Patients must be able to understand and agree to the present research protocol and they must provide a signed informed consent. G-For fertile women, a potential pregnancy need to be ruled out by appropriate lab 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-Patients with severe psychiatric disorders (as defined by DSM IV axis I or II) B-Patients with mental retardation severe or very severe. C-Patients affectd by clinically evident hypothiroidism D-Patients under medical therapies which cannot be administered in association with lithum. E-previously reported allergic reactions against lithium salts F-Patients affected by cardiovascular disorders and/or renal faliure. G-patients under diuretic therapy. H-epileptic patients I- Patients affected by motro neuron disorder s others then ALS. J-Presence of other neurological symptoms (sensitive, extrapyramidal, oculomotore, cerebellar, autonomic disorders). K- Previously reported loww compliance to drug therapies. L-Patients carrying PEG or tracheostomy


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients affected by amyotrophic lateral sclerosis (ALS)
MedDRA version: 6.1 Level: PT Classification code 10002026

Intervention(s)

Trade Name: CARBOLITHIUM
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lithium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): 1-EVALUATION OF SURVIVAL WITHOUT COMPLICATIONS 2-EVALUATION OF SURVIVAL WITH COMPLICATIONS

Secondary Objective: TO EVALUATE IN DETAIL: 1-INCREASE IN LIFE EXPECTANCY 2-DECREASE IN NEUROLOGICAL IMPAIRMENT 3-POTENTIAL BLOCKADE OF DISEASE PROGRESSION

Main Objective: TO EVALUATE THE EFFICACY OF LITHIUM SALT TO SLOW DOWN THE PROGRESSION OF ALS

Secondary ID(s)

2007-002379-16