New clinical trial in multiple sclerosis
1 April 2015
The Anne Rowling Clinic is part of a major new clinical trial to test whether existing drugs could be some of the first therapies in the world to slow disability progression in people with secondary progressive multiple sclerosis (MS).
Funded by an MRC and NIHR partnership and the MS Society, this groundbreaking trial is led by Dr Jeremy Chataway at UCL (University College London – the trial sponsor) and Anne Rowling Clinic Director Professor Siddharthan Chandran at The University of Edinburgh.
In the trial researchers will test the safety and effectiveness of amiloride (licensed to treat heart disease), fluoxetine (depression) or riluzole (motor neurone disease) against a dummy drug (placebo) in 440 people with secondary progressive MS – a late stage and untreatable progressive form of the condition.
A pipeline towards effective treatments
Up to 15 trial sites, including the Anne Rowling Regenerative Neurology Clinic, have been identified across England and Scotland and participants will be monitored for two years using MRI scans and other clinical measures to test for signs of MS disease progression; it’s hoped the drugs will work by protecting the nerves from damage.
The MS-SMART trial, as the study is called, is a phase 2 trial, an important stage in the development of potential new treatments. The purpose is to make sure the drugs are safe and demonstrate sufficient effectiveness before large numbers of people trial the drugs. If successful, this trial will start the process of developing a pipeline of drugs to modify the disease in people with secondary progressive MS; potentially revolutionising the way MS is treated in the UK and around the world.
MS-SMART will be testing drugs where the safety profile is already known – potentially shaving years off time usually needed to test potential newly-developed treatments. The study is also significantly cheaper than testing the treatments in three individual trials against a placebo.
While there are an increasing number of treatments for MS that can reduce the frequency or severity of MS relapses, there’s nothing that can stop the accumulation of disability in people with secondary progressive MS - it’s a huge unmet need in the treatment of the condition.
Dr Jeremy Chataway, Consultant Neurologist and lead researcher on this trial based at UCL
The three drugs for the trial were identified after a systematic review of previously published research of potentially neuro-protective treatments. Additional studies then followed to develop the methods and techniques due to be used in MS-SMART; both stages of this process were initiated and funded by the MS Society.
This is a landmark study that seeks to not only test three potential treatments but also showcase a new approach to clinical trials for progressive neurological conditions.
Professor Siddharthan Chandran, Clinical Neurologist at The University of Edinburgh & Director of Anne Rowling Regenerative Neurology Clinic
What is MS?
MS is a neurological condition where the immune system attacks myelin, a substance surrounding the nerves, which leads to delay and confusion in messages sent from the brain and spinal cord to parts of the body. It affects almost three times as many women as men and it’s an unpredictable condition which can leave people with MS unable to move.
Symptoms can include chronic pain, muscle spasm, problems with walking, balance, speech, vision and extreme fatigue; there are over 100,000 people with MS in the UK but currently no treatments which impact on progression.
People with MS aged 25-65 may be eligible to take part if they are not currently taking a disease modifying treatment and are able to walk at least 20 metres. For more details see www.ms-smart.org.
Funding of the trial
MS-SMART is an investigator led project sponsored by University College London (UCL). This independent research is awarded by the Efficacy and Mechanism Evaluation Programme (EME), a partnership between the Medical Research Council (MRC) and the National Institute for Health Research (NIHR), along with the Multiple Sclerosis Society (MS Society). Additional support comes from the University of Edinburgh, and the National Institute for Health Research University College London Hospitals Biomedical Research Centre.
Sanofi is supporting the study by donating the supply of riluzole for the trial.
For more information on the study go to www.ms-smart.org.
Read about our other clinical trials.
Listen to a BBC Radio Scotland interview about MS-SMART with consultant neurologist Dr Peter Connick (avaliable until Friday 1st May; 2hr 56 mins in).
Read an article about the trial on the BBC News website (31st March 2015)