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LiCALS

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

Specialty
Dementias
Portfolio Eligibility
Automatically eligible
ISRCTN 83178718
EudraCT 2008-006891-31
MREC N° 09/H1102/15
UKCRN ID 5745
WHO ID
Research Summary
Lithium has been used in the treatment of mental illness for 60 years, but a recent Italian trial (comprising only 44 patients) suggested that it might improve survival in people with motor neurone disease (MND; amyotrophic lateral sclerosis, ALS). Lithium modifies several cellular and molecular processes in the brain and spinal cord, and experimentally can protect the nervous system against various types of damage. Because Lithium is of interest as a ‘neuroprotective’ agent, and the Italian trial was too small to allow confident conclusions to be drawn, we propose a trial comparing lithium (at a dose designed to provide safe but also potentially effective blood levels) with placebo in 220 people with ALS. The trial will be supported by the Dementia and Neurodegenerative Diseases Research Network (DeNDRoN) within the UK Clinical Research Network (UKCRN) and by the MND Association. All volunteers will already be taking the standard treatment for ALS, and they’ll take either Lithium or placebo in addition. Volunteers will be randomly assigned to take either placebo or lithium tablets. The trial will be ‘double-blind’ so that neither the volunteers nor the doctors and nurses assessing them will know who is on lithium or the dummy tablets, but there will be a doctor at each site who’ll be unblinded, so they can monitor safetyeffectively. Volunteers will be followed for 18 months while taking the trial tablets. The main outcome measure is survival at 18 months, but we’ll also monitor side effects and safety, and the participants’ ability to perform activities of daily life using the ‘ALS Functional Rating Scale, Revised Version (ALSFRS-R), their quality of life (using a scale known as the EQ-5D), and possible psychological changes using the Hospital Anxiety and Depression Scale (HADS). The trial will take place at 10 MND Care Centres throughout England.
Study Type Interventional
Design Type Treatment
Disease(s) Motor neurone disease
Phase IV
Current Status Closed - follow-up complete
Closure Date 4/30/2010
Global Sample Size 220
Global Recruitment to Date
97%
Geographical Scope UK Multi-Centre
Lead Country England
Main Inclusion Criteria
1. 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.
2. Disease duration ≥6 months and ≤36 calendar months (inclusive), with disease onset defined as date of first muscle weakness, or dysarthria.
3. FVC ≥60% of predicted.
4. Age: ≥18 years (inclusive).
5. Sex: male or female. In the case of a female with childbearing potential, the patient must use adequate contraceptive measures and must not be pregnant or breast-feeding.
6. Continuously treated with riluzole for at 4 weeks (28 days inclusive) and stabilised at 100 mg/day (50 mg bid) without significant adverse drug reactions.
7. Capable of understanding the information given and giving fully informed consent.
Main Exclusion Criteria
1. Participation in another therapeutic study within the preceding 12 weeks or use of other investigational drugs or agents.
2. Tracheostomy, or assisted ventilation of any type during the preceding three months.
3. Existing gastrostomy.
4. Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS.
5. Presence of any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment.
6. Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT greater than 1.5 the upper limit of the normal range).
7. Renal insufficiency (serum creatinine >200 µmol/L [2.26 mg/dL]).
8. Evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms.
9. Known hypersensitivity to the study drug.
10. Likely to be uncooperative or to fail to comply with the trial requirements or to be inaccessible in the event of an emergency.
11. Subjects with significant haematological, biochemical and autoimmune abnormalities.
12. Unable or unwilling to use an effective method of contraception if a woman of childbearing age.
13. Patients with active inflammation/infection at screening or T0.
14. Patients already taking lithium in any form.
15. Presence of a medical condition contra-indicative to the use of lithium.
Chief Investigator(s)
Prof Ammar Al-ChalabiProf Nigel Leigh
Further details, please contact
Ms Marie Thornhill

King's College London
Department of Clinical Neuroscience
PO41
16 De Crespigny Park
London
SE5 8AF
UNITED KINGDOM

Tel: 020 71880616
marie.thornhill@kcl.ac.uk
Funder(s) Motor Neurone Disease Association (MNDA)
Sponsor(s) King's College London




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