MS-STAT2 Funding

Multi-Million Pound Trial to Investigate if Statins could become MS Treatment.

A phase 3 trial involving more than 1,000 people with multiple sclerosis (MS) is to investigate whether simvastatin could become a treatment for the condition.

The project will cost almost £6 million and is being funded by collaboration between the National Institute for Health Research (NIHR), the MS Society (UK), the National MS Society (US), the NHS and UK universities.

The trial will test simvastatin, a cheap cholesterol lowering drug, in people with the secondary progressive form of MS. There are currently no licensed treatments that target disability progression in people with this type of MS.

The research will be led by Dr Jeremy Chataway, UCL Institute of Neurology, who led the phase 2 trial into simvastatin that was published in The Lancet in 2014. It involved 140 people with secondary progressive MS. The research found those taking high doses of the drug had a significant reduction in the rate of brain atrophy (brain shrinkage) over two years and also had better disability and quality of life scores at the end of the study.

Dr Jeremy Chataway said:   “This drug holds incredible promise for the thousands of people living with secondary progressive MS in the UK, and around the world, who currently have few options for treatments that have an effect on disability. This study will establish definitively whether simvastatin is able to slow the rate of disability progression over a three year period, and we are very hopeful it will.”

Michelle Mitchell is Chief Executive of the MS Society:   “We’re incredibly proud to be co-funding the Simvastatin Trial. This is an absolutely momentous step forward in our quest to find an effective treatment for progressive MS. More than 100,000 people in the UK are living with MS and this research will offer a huge amount of hope to the majority of them.”

Stuart Nixon lives with secondary progressive MS:   “At the moment people like me are living with the prospect of our condition getting worse each day. This is the most exciting opportunity to change how we manage progressive MS. It would be amazing if this trial can show that an existing drug, costing just a few pence a day, can help with MS.”

Although the simvastatin trial received funding to start on 1 March 2017, there are many activities that have to happen before patients can be enrolled. This includes authorisations from the Health Research Authority (HRA), the Research Ethics Committee (REC) and the Medicines and Health products Regulatory Authority (MHRA); sourcing, packaging & distribution of the simvastatin and manufacturing of matching placebo. The trial will involve 1180 people with secondary progressive MS at almost thirty centres across the UK and will take six years to complete once patients start on trial.

Key facts:

• About Multiple Sclerosis (MS)

• About the MS Society

• About the NIHR HTA Programme

• About the NIHR

About Multiple Sclerosis (MS)

• MS affects more than 100,000 people in the UK.
• Symptoms typically appear when people are in their 20s and 30s.
• MS attacks the nervous system, it's often painful and exhausting and can cause problems with how we walk, move, see, think and feel.
• It is unpredictable and different for everyone.

About the MS Society

• The MS Society is here for people with MS, through the highs, lows and everything in between 
• We have a free helpline - 0808 800 8000 and information can be found on our website www.mssociety.org.uk
• We’re driving research into more – and better – treatments for everyone 
• Together we’re strong enough to stop MS

About the NIHR HTA Programme

The National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme funds research about the effectiveness, costs, and broader impact of health technologies for those who use, manage and provide care in the NHS.

It is the largest NIHR programme with a portfolio of over 400 national studies, and publishes the results of its research in the Health Technology Assessment journal, with over 700 issues published to date. The journal’s Impact Factor (4.058) ranks it 6/87 publications in the Health Care Sciences and Services category. All issues are available for download, free of charge, from the website. The HTA Programme is funded by the NIHR, with contributions from the CSO in Scotland, NISCHR in Wales, and the HSC R&D Division, Public Health Agency in Northern Ireland.

About the NIHR

The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. The NIHR is the research arm of the NHS. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government’s strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information visit the NIHR website, www.nihr.ac.uk.