Multicentric randomized placebo controlled trial of Lithium carbonate combined with Riluzole in patients with ALS - RCT ALS Lithium

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-006722-34-IT
• Date of registration: 11/12/2008
• Prospective Registration: Yes
• Primary sponsor: ISTITUTO SUPERIORE DI SANITA`
• Public title: Multicentric randomized placebo controlled trial of Lithium carbonate combined with Riluzole in patients with ALS - RCT ALS Lithium
• Scientific title: Multicentric randomized placebo controlled trial of Lithium carbonate combined with Riluzole in patients with ALS - RCT ALS Lithium
• Date of first enrolment: 23/06/2009
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006722-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1. Probable, probable-laboratory supported or definite ALS according to the revised version of the El Escorial World Fed. Neurology criteria with disease duration ≥ 6 and ≤ 36 months 2. Age ≥18 years and ≤ 75 years 3. Capable of understanding the information given and giving full informed consent 4.Continuously treated with Riluzole for at least 30 days and stabilized at 100 mg/day ( 50 mg bid) without significant drug reactions 5. FVC ≥ 60% of predicted 6. Female with child bearing potential, the patients must use adequate contraceptive measures and must not be pregnant or breastfeeding 7. Creatinine ≤ 1.5 mg/dl
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:
1. Presence of a medical condition contra-indicative to the use of Lithium or known hypersensitivity to the study drugs 2. Patients already taking Lithium in any form 3. Participation in other therapeutic study within the preceding 30 days or use of other investigational drugs or agents 4.Presence the following medical conditions: a. assumption of abuse drugs; renal insufficiency, hepatic insufficiency, heart disease, endocrine or hematological disorders; infective diseases including HIV; cancer; b. evidence of major psychiatric disorders or clinically evident dementia; c. plasmatic TSH > 20% with respect to normal values; d. use of diuretics 5. Abnormal ECG 6. Any medical conditions known to have an association with other neurological systems 7 Tracheostomy or assisted ventilation of any type during the preceding 3 months


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

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis

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)

Main Objective: Safety and efficacy evaluation of Lithium carbonate combined with Riluzole in ALS. Primary endpoint is patient survival at month 18.

Secondary Objective: Evaluation of necessity of PAV or tracheostomy and measure of the rate of functional deterioration over 18 month measured by change in the slope of ALSFRS-R, FVC, MRC an McGill quality of life. Evaluation of safety of the treatment in patiens with ALS

Primary end point(s): Patient`s survival in the two groups at 18 months

Secondary ID(s)

SLA_Litio