Evaluating multiple drugs simultaneously in an innovative clinical drugs trial
Motor Neurone Disease – Systematic Multi-arm Adaptive Randomisation Trial (MND-SMART) is a innovative clinical drugs trial in its design and reach. Multi-arm means that, unlike typical clinical trials which test a single treatment, MND-SMART will test more than one at the same time. The trial will initially test medicines that are already approved as treatments for other disorders in the UK. Trial participants taking the different treatments will be compared with a single group who receive a placebo (a dummy drug). This means that people in MND-SMART are more likely to receive an active treatment when compared to standard clinical trials where half of participants receive the placebo and half the active treatment.
What does taking part involve?
If you take part in the trial, you will be given one of two active drugs (Memantine Hydrochloride or Trazodone Hydrochloride) or a dummy drug (placebo) in a liquid form to take once a day.
During the trial, neither you nor the doctor or nurse treating you will know which medicine you are taking. How well the medicines are working will be reviewed whilst people are still taking the study drugs, rather than just at the end. If, at a review point, a medicine does not appear to be performing well you will be asked to stop taking it. You may be able to start MND-SMART again if new drugs are added to the trial (an ‘adaptive trial’)
During the trial you will be asked to take part in regular tests and assessments at appointments, including: blood tests, an ECG (a routine heart trace), breathing assessments, questionnaires about physical functioning and your mental health, and cognitive assessments (memory, problem solving etc).
Edinburgh (Anne Rowling Regenerative Neurology Clinic, University of Edinburgh) was the first trial centre open at the beginning of March, then Dundee in August. The third trial centre at Queen Elizabeth University Hospital in Glasgow has now opened in October 2020,
Trial centres across the UK will open throughout 2020/21 in: Aberdeen, Birmingham, Cambridge, East London, Inverness, Irvine, Newcastle, Salford and Southampton.
Due to the coronavirus pandemic, there has been a delay in opening of new trial centres across the UK.
Who can take part?
People diagnosed with MND, who are:
• over the age of 18
• living in the UK
• not pregnant or breastfeeding
How do I take part?
Register your interest on www.mnd-smart.org or alternatively contact the central trial team in Edinburgh by phone on 0131 242 7985 or 07341 887 737. The team will then contact you to give information and updates on when and where sites are opening.
Expiry date: N/A