MS-STAT2
1 November 2018
MS-STAT2 : Multiple Sclerosis - Simvastatin Trial 2
The MS-STAT2 clinical trial has been designed to test the effectiveness of repurposed simvastatin (80mg) in patients with secondary progressive MS (SPMS), to determine if the rate of disability progression can be slowed over a 3 year period.
SPMS results from a progressive neuronal degeneration that causes accumulated and irreversible disability affecting walking, balance, manual function, vision, cognition, pain control, bladder and bowel function. The pathological process driving the development of this disability is not known at present.
While treatments in the early stage of MS (relapsing-remitting MS, or RRMS) have become increasingly effective, there remains no current disease-modifying treatment (DMT) for SPMS. An earlier study, MS-STAT1, used magnetic resonance imaging (MRI) techniques to determine that patients taking simvastatin over a two year period resulted in a reduced rate of brain atrophy (a loss of neurons, or ‘brain shrinkage’) compared to those taking a placebo. That study took place with 140 patients, whereas the MS-STAT2 trial will increase patient participation considerably in an effort to determine whether simvastatin can become a DMT for SPMS.
Trial status: Ongoing. Recruitment open.
Funder: National Institute for Health Research
Sponsor: University College London
ISRCTN: ISRCTN82598726
- Publications
Blackstone J, Williams T, Nicholas JM, et al | Evaluating the effectiveness of simvastatin in slowing the progression of disability in secondary progressive multiple sclerosis (MS-STAT2): protocol for a multicentre, randomised controlled, double-blind, phase 3 clinical trial in the UK | BMJ Open 2024;14:e086414. doi: 10.1136/bmjopen-2024-086414
Thomas Williams, Sarah Alexander, James Blackstone, Floriana De Angelis, Nevin John, Anisha Doshi, Judy Beveridge, Marie Braisher, Emma Gray & Jeremy Chataway on behalf of the MS-SMART and MS-STAT2 Investigators | Optimising recruitment in clinical trials for progressive multiple sclerosis: observational analysis from the MS-SMART and MS-STAT2 randomised controlled trials | Trials 23, 644 (2022). https://doi.org/10.1186/s13063-022-06588-z