Phase 3 Trial in UK Soon to Test Statin, Simvastatin, in Slowing SPMS Progression

Phase 3 Trial in UK Soon to Test Statin, Simvastatin, in Slowing SPMS Progression

A large Phase 3 trial getting underway at sites across the U.K. will test the effectiveness of simvastatin, a widely used oral statin, in possibly treating secondary progressive multiple sclerosis (SPMS), the study’s sponsor, University College of London Hospitals (UCLH), announced.

The study, the largest ever undertaken for SPMS in the U.K., is named MS-STAT2 (NCT03387670). Its researchers will investigate simvastatin’s ability to slow or stop disability progression in 1,180 SPMS patients treated daily with the cholesterol-lowering medication, or placebo, for three years.

More than 30 sites across  England, Scotland, Wales, Ireland and Northern Ireland will be recruiting eligible adult patients, ages 25 to 65, through 2019. Information can be found here and on the trial’s registered document.

“Simvastatin is a very promising treatment prospects for secondary progressive MS in our lifetime. People with this form of the condition have been waiting for decades for a drug that works, which is why there’s such excitement around being able to start the trial. While it’s still early days, we believe simvastatin could change lives,” Jeremy Chataway, a UCLH consultant neurologist and study leader, said in a press release.

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An earlier Phase 2 trial (NCT00647348), called MS-STAT, showed that high-dose simvastatin (80 mg daily) improved cognitive function and slowed disease progression in treated SPMS patients.

The compound was also seen to reduce the rate of brain atrophy, or shrinkage, suggesting that it may hold anti-inflammatory proprieties, protecting nerve cells from damage in SPMS.

In the Phase 3 study, patients will start by taking one simvastatin tablet (40 mg) once each night for one month followed two tablets (80 mg total) at night for the next 35 months, or take placebos. Changes in disease progression and degree of physicial and cognitive disabilities will be measured in both patient groups using EDSS (Expanded Disability Status Scale) scores taken at study’s start and again at every six months throughout the study.

Secondary study goals include changes in walking ability and upper limb dexterity, and the treatment’s potential cost-effectiveness.

Financial support for this large, academic-led trial of repurposed simvastatin, whose brand names include Zocor,  comes from the U.K.’s MS Society, the National Institute for Health Research, the National MS Society (U.S), the British National Health Service (NHS) and participating U.K. and Irish universities.

“We are incredibly proud to be funding MS-STAT2, because we know what it could mean for people living with progressive MS. This condition is unpredictable, painful, and often exhausting, but finding an effective therapy means debilitating symptoms aren’t inevitable,” said Susan Kohlhaas, director of research at the MS Society.

“Today if you’re diagnosed with this form of MS you don’t have any options, but we’re getting closer to changing that, and hopefully delivering the solution everyone has been waiting for,” Kohlhaas added.

14 comments

  1. Kathy Allen says:

    Hi.
    I haven’t seen a comment regarding persons with Sec Prog MS who do not have high cholesterol? What would simvastatin ‘do; in that case? My cholesterol is low.
    Thanks, Kathy

    • Doug Taylor says:

      My wife has slowly worsening ms and her cholesterol is extremely low. Most sites say that cholesterol is necessary for nerve and myelin protection. We now believe that MAP bacteria is behind her ms and crohns.
      Lots of studies being done on that.

  2. Barbara R Moore says:

    This is incredible news! I hope the study results come out successful and the U.S. will not trail far behind them. I’m 61 with secondary progressive form and hope I’ll be young enough to see this come to fruition.

  3. Brian Fletcher says:

    Interesting… I’ve been taking Simvastatin for awhile now, for cholesterol, and have shifted into SPMS as well… It’s only anecdotal, but my MRI’s have been stable (I was getting them every 4-6 months the last 2 years I was on Tysabri).

  4. FB says:

    Personally, I think you’d want to be pretty desperate to consider statins – despite the endless spouting about how many millions of people already “safely” take them to lower cholesterol they are not without their own issues and potentially serious side effects. Given that the MS trials are using a higher dose that the “usual” one taken to lower cholesterol I suspect that the incidence of side effects will be higher than people on a “normal” dose would experience. One of the most commonly reported statin side effects is muscle pain and weakness, and when reports first started coming out regarding trialling stains in MS I wondered about the wisdom of using a drug type with these known side effects in a condition (MS) where people already frequently have problems with muscle pain and weakness.

    Statins lower cholesterol by affecting liver function, and there are a whole heap of other things which are affected as well, as it is not just the biological processes involving cholesterol which are changed. There can also be impacts from having cholesterol levels which are too low – especially with lack of energy. Contrary to what some people think, cholesterol which is too low can have a significant effect on your daily functioning. Who has MS and would welcome a further reduction in their energy levels? Not me, that’s for sure.

    In addition to muscle pain and weakness, statins can also damage your liver (which is why you have to regularly check on liver function with blood tests), they are known to increase Type 2 diabetes risks, and the jury is still not decided on whether they can affect your kidneys. And they can also cause cognitive issues, which is another thing many PwMS have enough of already.

    The Mayo clinic is generally pretty conservative in its views, so the information on this link will not be an exaggeration of reality. And even they note that “It’s possible, although unlikely, that one particular statin may cause side effects for you while another statin won’t. It’s thought that simvastatin (Zocor) may be more likely to cause muscle pain as a side effect than other statins when it’s taken at high doses”.
    https://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/statin-side-effects/art-20046013

    I do not have high cholesterol, but I do have some risk factors for CVD so I was put on a statin to reduce my cholesterol levels. In less than six weeks I was virtually immobilised through muscle pain and weakness, was so low in energy I could barely get out of bed, and I had two falls because my legs collapsed underneath me, so count me out from going “whoopee” about statin trials in MS.

  5. Doug Floyd says:

    What about people who are in their 70’s – if trial is successful would those people be eligible for drug? Surely age should have no bearing on whether they can use it. I have SPMS and have been waiting for a drug like this forever. I have tried everything else, including Betaseron which literally put me in a wheelchair and did not benefit my disease. I started the disease with
    “possible” MS, and was subsequently diagnosed with Remitting Relapsing, then Relapsing Progressive, and now SPMS.

    Doug Floyd

    Nova Scotia

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