In response to the rapidly evolving circumstances surrounding Coronavirus, in accordance with guidance from the research sponsors, the difficult decision has been taken to pause recruitment to MND-SMART.
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 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).
The first research centre is open in Edinburgh (Anne Rowling Regenerative Neurology Clinic, University of Edinburgh).
Trial centres across the UK will then open throughout 2020 in: Aberdeen, Birmingham, Cambridge, Dundee, East London, Glasgow, Inverness, Irvine, Newcastle, Salford and Southampton.
Alongside pausing recruitment, there will also be 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?
Recruitment has been paused, please see more information here.
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