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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.