Simvastatin belongs to a class of drugs called statins which are used to lower cholesterol. A previous phase II study (MS-STAT1) was carried out in 140 people with SPMS who took either simvastatin or inactive placebo for two years. The study found that the level of brain tissue loss, an indicator of MS progression, was lower in the simvastatin group.
This new phase III study (MS-STAT2) will investigate this further in a larger group of people. The researchers aim to recruit 1180 participants with SPMS at study centres in the UK who will take either simvastatin (80mg/day) or placebo for 3 years. This dose of simvastatin is at the top end of the dose range normally recommended for lowering blood levels of cholesterol. The main measure of progression will be an increase in EDSS which lasts for 6 months or more. Participants will also be monitored for other measures of MS progression and will be asked to complete questionnaires to measure the impact of MS on their day-to-day living.
The trial is due to start this summer and is not yet ready to recruit participants but you can register your interest in taking part.