Current phase of trial: phase 3
Type of MS: secondary progressive MS
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How does simvastatin work?
Simvastatin is a tablet used to treat high cholesterol. Statins are thought to be anti-inflammatory and protect nerves from damage.
We're funding research to understand how simvastatin works in secondary progressive MS.> Find out more about our simvastatin research
Phase 3 trial - MS-STAT2
This late stage trial will fully test if simvastatin can slow progression. It will involve 1,180 people with secondary progressive MS. It began in March 2017 and will take six years to complete. We expect recruitment for the trial to open in late summer 2018.
Phase 2 trial - MS-STAT
The trial involved 140 people with secondary progressive MS and compared two doses of simvastatin with a placebo (dummy) drug. Researchers found that people taking high dose simvastatin had reduced brain atrophy (shrinkage) better end of study disability scores compared with those taking placebo.
Results were published in the Lancet in March 2014.
In that phase 2 trial simvastatin was generally well tolerated and no one reported any major side effects. The phase 3 trial will now monitor the safety of simvastatin in a much larger number of people with MS.
General side effects
Simvastatin has been used to treat high cholesterol for many years. Commonly reported side effects include: dizziness, fainting, nosebleeds, joint or muscle pain, headache, nausea and digestive problems.
High dose simvastatin
In June 2011 the Food and Drug Administration, which is the US drugs regulator, issued new safety recommendations for simvastatin.
It said that muscle injury (or myopathy) is a risk associated with the 80mg/day higher dose, which will be used in MS-STAT2.
How does simvastastin compare with current therapies?
There are no licensed treatments that can slow or stop progression for people with secondary progressive MS.
When is simvastatin likely to become available?
A phase 3 trial will test if simvastatin could become a treatment for secondary progressive MS. This trial will take six years to complete and results are expected in 2023.
We will keep you updated on the progress of simvastatin.