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Disappointing news from the UK based lithium clinical trial

14 February 2012

Results from a recent clinical trial into motor neurone disease (MND), involving people with MND in England have been announced and show that lithium carbonate is ineffective at treating the disease.

The trial, known as the ‘LiCALS trial’, was co-funded by the Department of Health and the MND Association. It tested for safety and effectiveness (efficacy) of lithium in 215 patients with ALS* across England.

While it has been shown to be safe and well tolerated, it did not demonstrate a significant increase in survival, compared to patients receiving the placebo (dummy drug) together with riluzole.

The lithium clinical trial principal investigator, Prof Ammar Al-Chalabi from King’s College London said:

“We are most grateful to all of the participants for taking part in the LiCALS study. Although the results are disappointing, it is thanks to the dedication and commitment of those that took part in LiCALS that the trial has allowed the development of a trials network of ten centres in the UK, which will be of great benefit for rapidly testing future therapies. For that we are extremely grateful.

“The results of the study will be published in scientific or medical journals and submitted to regulatory authorities. Participants will not be personally identified in any report or publication.”
Commenting on the lithium clinical trial, Dr Brian Dickie, Director of Research Development at the MND Association said:

“As many people will know, when lithium was first proposed as having benefit in MND, a couple of small, short-term trials were performed to establish whether the drug had a large and rapid effect on physical changes in disease progression. This trial, by contrast, was developed to ask whether the drug had a more subtle benefit over a longer time course, as is the case with riluzole, using survival times as the primary measure. The only way to answer this question was by performing larger, lengthier and more comprehensive studies.
"While the result is deeply disappointing, we now have a clear answer.

“Lithium can be described as a messy drug. It can act in multiple ways in the body, producing potentially beneficial effects as well as possible unwanted side effects. An overall beneficial effect, even modest, would have refocused scientific interest in the drug to try and separate ‘the good from the bad’ with the longer-term goal of developing more effective compounds. This is a strategy that is presently being pursued with regard to riluzole, in a project co-funded by the ALS Association, the University of Reading and ourselves.

“This trial was the first of its type in the UK, devised and run by clinicians without the need for drug company funding. A number of MND clinics that previously had little or no experience in clinical drug trials for MND have developed vital expertise and confidence in delivering trials to the highest standards. This can only help make the UK a more attractive place in the future for drug companies looking to push potential treatments from lab to clinic.”

Two hundred and fifteen people with MND took part in this trial, each giving up their time to help find us the answers. We’d like to thank those that have taken part in this trial.

If you are affected by MND and have any questions about this news then please contact MND Connect on 08457 626262 or at
mndconnect@mndassociation.org

Contact:

Farah Nazeer Director of External Affairs
07876 574844
farah.nazeer@mndassociation.org

Notes to editors

*ALS, amyotrophic lateral sclerosis is the most common form of MND.

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