LiCALS Version 1

• Research type

  Research Study

• Full title

  A double-blind randomised controlled trial of Lithium Carbonate in patients with Amyotrophic Lateral Sclerosis

• IRAS ID

  14735

• Contact name

  Peter N Leigh (previous), Ammar Al-Chalabi (current)

• Sponsor organisation

  King’s College London

• Eudract number

  2008-006891-31

• ISRCTN Number

  awaiting

• Clinicaltrials.gov Identifier

  N/A

• 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, also known as 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 Ó?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 MND. The trial will be supported by Neurodegeneration and Dementia 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 MND, 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 Ó?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 safety effectively. 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.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/15

• Date of REC Opinion

  17 Feb 2009

• REC opinion

  Favourable Opinion