MND-SMART
Research type
Research Study
Full title
Motor Neurone Disease Systematic Multi-arm Adaptive Randomised Trial (MND-SMART)
IRAS ID
227793
Contact name
Fiach O'Mahony
Contact email
Sponsor organisation
University of Edinburgh
Eudract number
2019-000099-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 11 months, 29 days
Research summary
Motor neurone disease (MND) is devastating neurodegenerative disorder, which causes progressive muscle wastage affecting the ability to walk, speak, swallow and breathe. Half of people diagnosed with MND die within two years of diagnosis. There is no cure for MND and only one licensed drug in the UK that extends life by 2-3 months.
To find new treatments for people with MND we have designed a clinical trial, MND-SMART. The trial will be multi-arm, meaning it can test more than one potential drug at a time. It will also be adaptive which means the trial may change whilst it is still running. Drugs will be tested in 4 stages in MND-SMART and data reviewed at the end of each stage whilst participants are still taking the study drugs. If the results of one of these stages meet the trial team’s agreed criteria the drug will continue to be tested in the next stage. If the results do not meet the criteria, indicating the drug will not benefit people with MND, it be removed from the trial.
We plan to test drugs that are currently licensed to treat another disease, where information from clinical trials and experiments suggests they may also slow progression of MND, this is called drug repurposing. Whilst the trial is running, we will continue to look for other drugs that might slow the progression of MND and add these into the trial.
This multi-arm, adaptive trial design is innovative in MND research and means we can test more treatments in a shorter space of time.
The first two drugs that will be tested in MND-SMART are Memantine, currently used to treat Alzheimer’s disease, and Trazodone, currently used to treat depression. Patients will be recruited from sites across the UK.REC name
West of Scotland REC 1
REC reference
19/WS/0123
Date of REC Opinion
2 Oct 2019
REC opinion
Further Information Favourable Opinion