E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients affected by amyotrophic lateral sclerosis (ALS) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10002026 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
TO EVALUATE THE EFFICACY OF LITHIUM SALT TO SLOW DOWN THE PROGRESSION OF ALS |
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E.2.2 | Secondary objectives of the trial |
TO EVALUATE IN DETAIL: 1-INCREASE IN LIFE EXPECTANCY 2-DECREASE IN NEUROLOGICAL IMPAIRMENT 3-POTENTIAL BLOCKADE OF DISEASE PROGRESSION |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
|
E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
1-EVALUATION OF SURVIVAL WITHOUT COMPLICATIONS 2-EVALUATION OF SURVIVAL WITH COMPLICATIONS |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
LO STUDIO PREVEDE IL CAMBIAMENTO IN APERTO OVE SI VERFICHI UNA DIFFERENZA > 50% TRA I DUE GRUPPI |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |