Blind Trial, Spot The Difference

Allan McDonald

I am in my final stages of this trial, and was asked for my thoughts on it, so…..

This is a phase 3 trial (final phase) exploring the use of simvastatin for secondary progressive MS. MS-STAT2 involves just under 1000 people across 30 sites in the UK. Participants are randomly assigned to take Simvastatin (80 mg/day), or a placebo, for three years. The main aim of the trial is to confirm that it can slow or stop disability progression for people with secondary progressive MS. If so, it has the potential to become one of the first disease modifying therapies for people with secondary progressive MS. 

The results of earlier trials suggest Simvastatin could improve levels of disability and slow disease progression. It also reduced the rate of brain atrophy (shrinkage), suggesting the treatment could protect nerves from damage, slowing the progression of disability and cognitive decline. Simvastatin is currently used to treat high cholesterol. These MS benefits were independent of the medicine’s effect on cholesterol levels.

The demands of the trial were not particularly arduous. It involved a visit to the hospital every 3/6 months, doing various cognitive tasks, and checking my walking speed – all the usual stuff.

Good Points

• Trying a new drug treatment which I think will be of great benefit myself, and to many others with MS.
• The trial is controlled by UCL. It is being managed by The National Hospital for Neurology. They seem to be the UK experts in MS and really know what they are talking about, and doing. I’m lucky enough to be looked after by that hospital, so I knew of some of the trial consultants already.
• Simvastatin is already approved for use in the UK for treating high cholesterol. Therefore it should make approval for use with MS easier if the trial is successful.
• I understand Simvastatin is relatively cheap, so it may not be as much of a fight to get it prescribed.
• As it is approved already, any side affects are known. (I haven’t been able to eat grapefruit for three years, but apart from that I don’t appear to have suffered).

Not-So-Good Points

• As it is a “double blind” trial, nobody knows if they are on the drug or a placebo. So yes, I may have had early access to a new drug, but I could equally have been taking “pink smarties” for three years!
• Being an early recruit to the trial, I finished in Autumn 2021. The last recruits for the trial started in August the same year. Therefore I could potentially have a full three years without the drug until the trial finishes. If I am on Simvastatin, and it has been working for me, will I progress further while waiting for approval?

The trial is due to finish in 2024, with approval hoped for in 2025. 

I know others at the centre are taking part, and it would be interesting to know if you had similar experiences, or have similar feedback.