MS SMART - First '3 in 1' MS trial completed
Oct 2018: Researchers have completed the MS-SMART clinical trial on multiple sclerosis (MS) in which 3 different drugs were tested at the same time instead of 1 by 1 by 1 - a world first in progressive neurological disease research.
MS-SMART was a 'multi-arm' study which meant that tests of all three drugs could be completed in 5 years instead of around 15; the time it would have taken if trialled individually under usual practice, it was also carried out at much less cost.
The three drugs in the MS-SMART study were not found to be effective, but researchers said that the trial has broken new ground and established a benchmark for future trials not only for MS but also other neurodegenerative disorders such as the dementias.
The study was funded by a partnership between the Medical Research Council, the National Institute for Health Research, the MS Society UK and the National MS Society (US). The MS-SMART trial was a national trial taking place at a number of UK sites including the Anne Rowling Regenerative Neurology Clinic. The study tested the safety and efficacy of three repurposed drugs (used to treat other conditions) in 445 people with secondary progressive MS (SPMS), for which currently there are no treatments. All three drugs had been selected based on promising effects in experimental and pilot human studies.
Participants took amiloride (used to treat heart disease), riluzole (a treatment for motor neurone disease), fluoxetine (used for depression) or a placebo pill for two years. MRI scans and other clinical measures such as walking, eyesight and simple thinking tests were done before and after treatment to test for signs of MS disease progression. Researchers found no clinical effect of the three drugs being tested.
While we are disappointed with the result, this study improves our chances of success in the future. We have shown we can run faster trials, which will speed up the development of new treatments. It will also significantly improve our understanding of the biology of progression.
Unfortunately these three drugs aren't the right ones for progressive MS, but we will ramp up our efforts to find treatments for progressive neurological conditions, and we are confident we will succeed.
Thank you to our participants
The research team and funders would like to thank all the participants and their families for their time, commitment and energy in taking part in the MS-SMART trial.
Questions or feedback?
If any of the participants would like to ask any questions or have any feedback about the trial then please don't hesitate to contact Dawn Lyle, Research Project Coordinator 0131 465 9512 or email Dawn on dawn.lyle1@nhs.net
A meeting is being planned for all the participants who attended the MS SMART trial at the Anne Rowling Clinic, in which they will find out which of the drugs tested they were taking (un-blinding), this will be held in early 2019. A member of our team will be in touch.