MS-STAT2 – Simvastatin for Secondary Progressive MS

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Thank you to Prof. G, MouseDoctor and the Barts MS team for letting us reach out to you about the MS-STAT2 study! Are you interested in taking part? We would love to have you involved!

Follow the link for more details and to register your interest:

www.ms-stat2.info

MS-STAT2 – What is it?

The MS-STAT2 study is a 3 year clinical trial testing whether high dose simvastatin can slow down the rate of disability progression in SPMS. This builds upon the very positive results of our previous study, MS-STAT1:

  • Simvastatin slowed down the rate of brain shrinkage (whole brain atrophy) by 43% per year
  • Other benefits were also seen on disability progression and some cognitive outcomes

See here for further details: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62242-4/fulltext

What does it involve?

The 3 year study involves taking tablets once a day. Importantly, there is a 50% chance of being on the simvastatin tablets for 3 years, and 50% chance of being on placebo – nobody will know what you are taking until the end of the study. This is the only way we can be sure if the simvastatin really works. There are a total of 10 visits to hospital over the 3 years of the study so we can closely monitor your progress. We are able to compensate you for travel expenses (up to £30 per visit), and the visits can be done at any of the hospitals below:

Who can take part?

We are recruiting people with secondary progressive MS (a steady progression, rather than relapses, has been the major cause of increasing disability over the last 2 years). Other key points include:

  • Age 25-65, inclusive (so you can join the study so long as you do so before your 66th birthday)
  • Disability: participants experience some disability (hence things like walking and balance are often starting to be affected), but are still able to walk 20m with a frame / walker (on a very flat floor with a doctor walking with you!) (aka. EDSS 4.0-6.5 inclusive)

Unfortunately you cannot take part if any of the following applies:

  • Primary progressive or relapsing remitting MS
  • You are already taking a statin
  • You are taking another “disease modifying drug”. If any new drugs become available on the NHS for SPMS during the course of the trial, however, being in the study will not stop you from being able to take them

If you are unsure about whether you are able to take part, the best thing to do is register your interest in the trial via the above link, and we can then discuss things with you.

How are we getting on?

We already have over 250 patients in the trial around the UK, and today we have recruited our 100th patient at UCL alone! Whilst this is great news, we still have a lot of work to do to reach our target of 1180 patients. Are you interested in joining the MS-STAT2 team?

Here’s the link again for further info and to register your interest in taking part:

            www.ms-stat2.info

Jeremy Chataway, and the MS-STAT2 team!

If any healthcare professionals would like more information, you can email the MS-STAT2 team directly at UCLH.QSMSC@nhs.net

About the author

Tom Williams

12 comments

    • Thanks Tony. I assume you are alluding to combination therapies? I certainly share the opinion that combining different treatments may well be the future of MS therapies. Designing trials for combination therapies, however, quickly becomes prohibitively expensive due to the number of treatment groups involved. If simvastatin is proven to be effective, however, I certainly hope one of the next steps will be combing with other DMTs. Siponi-statin anyone? Cladri-statin?

  • Phase 2 from 2008-2011, not published until 2014. Now phase 3 not initiated until 2019 for 3 year study that won’t be finished until 2022? Even by MS standards that is slow. Nothing personal, but why the long wait?

    • This has mainly been related to funding. There is no pharmaceutical involvement in this study, and hence after the phase 2, it has taken a long time to put together the required resources. MS-STAT2 is funded by a collaboration between the National Institute for Health Research (NIHR), the MS Society (UK), the National MS Society (US), the NHS and UK universities. If proven to be effective, this source of funding should at least mean the cost of providing the treatment can be kept low.

  • What’s the difference between the actual drug used and trial method for the apparent failed 80 mg atorvastatin trial for MS and the MS simvastatin trial?

    • The STAyCIS trial (atorvastatin in CIS) was negative for number of patients developing >2 new T2 lesions or having relapses. The trial was underpowered though, only recruiting just over half the number of patients they originally planned to. It was also only a one year study, so harder to show benefit. Interestingly though, overall those on atorvastatin developed significantly fewer new T2 lesions than those on placebo.

      Simvaststin and atorvastatin are similar. Both are lipophilic, and hence cross the blood brain barrier better than most other statins. In contrast to the STAyCIS trial, we are recruiting secondary progressive MS rather than CIS, with 3 year follow-up rather than 1. Our primary outcome is disability progression, rather than relapses and MRI (although we will look at this as well).

      Hopefully with all your help, unlike STAyCIS, we will reach our recruitment target!

  • I know we are a bolshie bunch, but is there otherwise any reason why PPMSers have been excluded? NICE doesn’t seem to like us either …. Otherwise I would love to take part (if I wasn’t too ancient and have been on atorvastatin for a long time). Nevertheless I wish you and your participants well.

    • Good question RB. The short answer is that for the MS-STAT2 study, the power calculation is based upon the previous MS-STAT1 data (aka we have used the MS-STAT1 results to tell us how much of a treatment effect we can expect in MS-STAT2, and hence how many participants we need in order to demonstrate a clear result). This means we need to make the study as similar to STAT1 as possible, hence SPMS only, in order for these assumptions to be valid.

      Now I appreciate this is a bit of a cop-out answer, because then the obvious question is “so why not PPMS in the previous MS-STAT1 trial then?” When this decision was made I was still in medical school, so I will check with the boss Prof. Chataway on Monday morning and get back to you!

    • RB sorry for delay in getting back to you. Discussed with Prof. Chataway – apparently the initial decision to include SPMS only in the MS-STAT1 study was made by the statisticians. Their aim was to try to ensure the participants in the trial were as similar as possible, hence avoid any theoretical variability in results that could be brought in by including PP and SPMS.

      I personally to do not think the underlying disease processes of PP and SP are likely to be different, and hence if it is shown that simvastatin works in SPMS, hopefully it will soon be followed up by similar studies in PP.

      Thank you for you interest!

  • Hi Tom,
    Thanks for your post and apologies for late reply. Do you know why Bristol (Southmead Hospital, Bristol and Avon MS aka BrAMS) no longer on list? (It’s listed with a * and form would not allow me to continue).
    All the best with recruitment to trial, SPMS is a huge unmet clinical need!

    • Hi Annonie Mouse,

      Unfortunately Bristol no longer felt that they had sufficient resources to see people in the trial there – a disappointment for us all.

      We are still trying to set things up with Gloucester, and Taunton is another possible site that may join the trial soon. Beyond that, Cardiff and Oxford would probably be the nearest sites to the Bristol area.

      Thank you for your interest!

      Tom

By Tom Williams

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