A randomised placebo-controlled trial of Lithium carbonate in Amyotrophic Lateral Sclerosis (LiCALS) - LiCALS

Phase 1

• Conditions: Amyotrophic Lateral Sclerosis (ALS); MedDRA version: 9.1Level: LLTClassification code 10002026Term: Amyotrophic lateral sclerosis

• Registration Number: EUCTR2008-006891-31-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-28
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Patients with Possible, Laboratory-supported Probable, Probable or Definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria (The ‘Airlie House Statement’: http://www.wfnals.org)
These criteria are internationally accepted research diagnostic criteria with high specificity and sensitivity. The onset form (bulbar or limb) and disease type (familial or sporadic) will be recorded; source documents will include a full report of an electromyogram (EMG) reported by an experienced neurophysiologist as compatible with ALS.
• Disease duration =6 months and =36 calendar months (inclusive), with disease onset defined as date of first muscle weakness, or dysarthria.
• FVC =60% of predicted within 1 month prior to randomisation
• Age: =18 years (inclusive).
• In the case of a female with childbearing potential, the patient must not be pregnant or breast-feeding. Women of childbearing potential will have a urine pregnancy test before randomisation; and at each clinic visit. The results of those must be negative. Women of childbearing potential should use two barrier methods of contraception.
• Continuously treated with riluzole for at least 4 weeks prior to screening (28 days inclusive) and stabilised at 100 mg/day (50 mg bid) without significant adverse drug reactions.
• Capable of understanding the information given and giving fully informed consent prior to any study specific procedures.

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

• Participation in another therapeutic study within the preceding 12 weeks or use of other investigational drugs or agents.
• Tracheostomy, or assisted ventilation of any type during the preceding three months.
• Existing gastrostomy, unless elective and not currently used for nutritional support or hydration.
• Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS.
• Presence of any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment.
• Confirmed hepatic insufficiency or abnormal liver function (ALT greater than 1.5 the upper limit of the normal range) within one month of randomisation. That blood test may be repeated in the case of initial abnormal results; if the AST and ALT return to normal, the patient may then be included in the study.
• Renal insufficiency (serum creatinine >200 µmol/L [2.26 mg/dL]) within one month of randomisation. That blood test may be repeated in the case of initial abnormal results; if the AST and ALT return to normal, the patient may then be included in the study.
• Recorded diagnosis or evidence of major psychiatric disorder or clinically evident dementia.
• Known allergy or hypersensitivity to lithium, or its excipients.
• Likely to be uncooperative or to fail to comply with the trial requirements or to be inaccessible in the event of an emergency.
• Subjects with significant haematological, biochemical and autoimmune abnormalities, as judged by the study physician.
• If a woman of childbearing potential, unable or unwilling to use effective contraception (two barrier methods) during the study.
• Patients with active inflammation/infection at screening or Baseline (Day 0). Patients presenting with active inflammation/infection can be reassessed at a later date, and included in the trial if the infection/inflammation has cleared.
• Patients already taking lithium in any form.
• Presence of a medical condition contra-indicative to the use of lithium, according to the BNF (http://www.bnf.org/bnf/)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified