MS-STAT2 Update

image of Dawn Lyle

July 2020: We chatted to Dawn Lyle, Research Project Coordinator and Lead Research Nurse at the Clinic, for an update on the MS-STAT2 clinical trial.

Dawn leads the day-to-day work in the Anne Rowling Clinic on the MS-STAT2 project - a clinical drug trial for secondary progressive multiple sclerosis devised by researchers at UCL (University College London).

 

Tell us a bit about yourself

I’ve been a member of the team here at the Clinic since 2011. After qualifying as a registered nurse, I worked in a range of different specialties before becoming a research nurse and deciding to specialise in neurology research in 2011. 

Outside of work I enjoy live music, cycling, dance classes and subjecting the family to my baking.

 

What is MS-STAT2 about?

MS-STAT2 is a UK-wide phase 3 clinical drug trial that is testing whether a high dose of the drug simvastatin can be used in people the secondary progressive form of MS (SPMS) to slow the progression of their MS. It is a drug that is currently licensed in the UK to lower cholesterol. We’re a recruitment site for the trial and hope to enrol approximately 110 people with SPMS to take part. Currently we have 90 people signed up and participating through the Clinic. 

 

Why is a treatment for secondary progressive MS (SPMS) so important?

SPMS is the stage of MS that follows relapsing remitting MS. Someone with MS is diagnosed with the secondary progressive form when their condition becomes progressively worse and their level of disability increases. 

There are currently very few treatments for SPMS so the search of treatments to slow the disease is very urgent for people with MS and their families. In the course of my day to day work I meet many inspiring people with SPMS and I personally hope that we can identify an effective treatment to slow down progression of their MS.

 

What do we know so far about simvastatin?

The UCL Institute of Neurology, who are coordinating the UK trial, led a phase 2 trial into simvastatin and published the results in 2014. It involved 140 people with SPMS and found that those taking high doses of simvastatin had a significant reduction in the rate of brain atrophy (brain shrinkage) over two years and also had better disability scores at the end of the study. The researchers concluded that high doses of simvastatin might be a treatment option for SPMS in the future and so progressed to develop this phase 3 trial involving far more participants over a three year period. These different phases of a clinical trial are necessary to ensure the safety and effectiveness of the drug before potentially being licensed for widespread use.

 

How has Covid-19 affected the trial?

As lockdown hit we had to pause recruitment in accordance with government advice. We did continue to support those people who were already in the trial though, as we were able to adapt the trial to contact participants by phone. This allowed us to gather the information we needed to complete the study visits and we then arranged delivery of the study medication to their homes. Adapting the trial in this way ensured the safety of the study participants whilst also managing to continue the trial.

 

What does taking part in the trial involve and how can someone get involved?

This 3 year trial involves 4 appointments over a 6 month period, followed by less frequent 6 monthly visits. All visits take place at the Anne Rowling Clinic and involve neurological examinations, blood tests, walking distance tests and cognitive testing so we can clearly track what effect the drug may be having.

We’d be delighted to hear from anyone with SPMS interested in taking part once we are ready to restart recruitment. Please get in touch with me by email on dawn.lyle1@nhs.net or call 0131 465 9512. Alternatively you can go online to note interest in the trial

 

Find out more details on the trial project page.

 

MS-STAT2 is funded by the MS Society, UCL and the National Institute for Health Research.

This article was published on: Wednesday, July 08, 2020
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