About MS-STAT2
Information about the trial.
September, 2024.
April, 2023.
Having completed recruitment for the U.K. MS Society Simvastatin trial MS-STAT2 in 2021, we are in the process of concluding the trial, with many of our participants in the final extension phase. Find out about other MS Society trials and studies.
The Human story of multiple sclerosis (MS) research
People with MS and researchers at Queen Square have worked together to produce the film ‘What it's like to have MS and the exploration of clinical research’. This film tells the human story of clinical research, and was commissioned and funded by the NIHR University College London Hospitals Biomedical research Centre.
The MS-STAT2 trial
- : The trial extension, and staying involved in the trial.
- MS Society blog post (December 2021): “We have the wonderful participants to thank” – Simvastatin trial completes recruitment.
- MS Society blog post (November 2020): BehindTheTrials: the people finding out if a cholesterol drug can slow MS progression.
- Covid-19 and implications for patients.
Multiple sclerosis (MS) is a progressive neurological disorder of the brain and spinal cord. It affects approximately 120,000 people in the UK and 2.5 million people globally. Most people with MS experience two stages of the disease: Early MS – Relapsing-Remitting MS (RRMS), which is partially reversible, and Late MS – Secondary Progressive MS (SPMS), which affects the majority of patients, usually after 10 to 15 years after diagnosis.
SPMS results from progressive neuronal degeneration that causes accumulating and irreversible disability affecting walking, balance, manual function, vision, cognition, pain control, bladder and bowel function. The pathological process driving the accrual of disability in SPMS is not known at present.
Immunomodulatory anti-inflammatory disease modifying therapies (DMTs) are increasingly effective in reducing relapse frequency in RRMS, however, they have been unsuccessful in slowing disease progression in SPMS. This is the overwhelming conclusion from an analysis of 18 phase 3 trials (n=8500), of which 70% of the population had SPMS, all performed in the last 25 years. There is no current DMT for SPMS.
In an earlier study (MS-STAT1), 140 people with SPMS were randomly assigned to receive either placebo or simvastatin for a period of two years. The investigators found that the rate of brain atrophy (loss of neurons - ‘brain shrinkage’), as measured by magnetic resonance imaging (MRI), was reduced in patients receiving simvastatin compared to those taking placebo. Several other long-term studies have also demonstrated a relationship between the rate of brain atrophy and the degree of impairment.
MS-STAT2 is designed to test the effectiveness of repurposed simvastatin (80mg) in a phase 3 double blind, randomised, placebo-controlled trial (1:1) in patients with secondary progressive MS (SPMS), to determine if the rate of disability progression and related MRI changes can be slowed over a 3-year period.
It is now in its final stages, having successfully recruited 964 participants across the UK, just over 500 remain active in trial, with almost 2/3 being in the final extension phase of the trial. It is expected to conclude in late 2024, and provide results in early 2025.
August 2021
We're delighted to announce that we’ve completed recruitment. Find out about other trials and studies.
MS-STAT2 Newsletter (March 2020): Covid-19 and implications for patients
FAQS
What is the eligibility criteria?
Among others, prospective participants’ need
a diagnosis of Secondary Progressive Multiple Sclerosis (minimum of 2 years)
evidence of with progression of the disease (not relapses)
How long is the trial?
Recruitment is expected over 2 years
Each participant is in trial for 3 to 4.5 years
Overall we expect the trial to be 5 years
How many visits in total?
For most this will be 10 to 13 visits during the trial period, which lasts up to 4.5 years
How frequent are the visits?
Screening, Baseline and the 1st follow up visit will be roughly monthly for 1st three months
A telephone call is completed at 3 months
Thereafter visits are every 6 months
Who will be at the visits?
Members of the study team including: research nurses; clinical research fellows both treating physicians and independent assessors
We also have a strong admin support team who will help book appointments either at the visit or by telephone. They will also help to arrange travel reimbursement
Will there be travel reimbursement available?
The study has a small allowance towards travel per visit
Will transport be booked for travelling to NHNN for trial?
No. Participants will be required to make their own travel arrangements, but a small contribution can be made towards their travel costs
Participant Withdrawal
The study is completely voluntary and the participant can withdraw from the study at any point with no explanation given, and no change to their standard of care
Which medication is used?
Simvastatin is the repurposed cholesterol drug, licensed to lower the cholesterol level in the blood. It is a common cholesterol lowering medication that has been used in millions of people around the world.
All Participants must be fully aware that they may not be on the active treatment of Simvastatin. Only 50% of participants will receive Simvastatin and 50% will receive placebo (dummy pill) as this is a double-blinded study.
Why Simvastatin?
An earlier study (MS-STAT1) showed a likely neuroprotection effect on MRI scans.
Will participants know what drug they are on?
No. This is a double-blinded trial meaning the treating doctors and nurses, nor the participants, will be aware of what drug they are on through the trial.
Side effects: what to expect?
Simvastatin is generally a very safe drug. There are rare serious side-effects in a few people which will be fully discussed with all potential participants.
Do participants need to register to the UK MS Register to take part in the trial?
No there is no obligation to sign up with the UK MS Register although we do strongly suggest this.
Can participants take part in MS-STAT2 if they are participating in another clinical trial?
No. However when they finish their existing clinical trial, following a 6 month washout period, they could be considered for the MS STAT2 trial. A washout period is defined as the time between treatments i.e., stopping one medication and starting another.
Sites
Our 31 sites are geographically spread across England, Scotland, Wales, Northern Ireland and Eire, with UCLH in London as the lead site, which opened in 2018.
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 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.
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 MS Society
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.