Memantine, Trazodone and Contemporaneous Placebo – An Unblinding Update

Dec 2024: Final database lock for the discontinued memantine, trazodone and contemporaneous placebo arms has been completed. Former trial participants randomised to these arms can now be unblinded to their treatment allocation.

We are delighted to share that we have now randomised nearly 900 participants to MND-SMART across 22 sites in the UK. All trial sites are continuing to work as quickly as they can to recruit to amantadine and contemporaneous placebo arm.

In September 2023, memantine, trazodone and contemporaneous placebo arms were discontinued from MND-SMART as the stage 2 analysis showed there was no benefit in slowing MND progression. As a result, all participants have now safely exited the trial. 

Following intensive data cleaning and arm closeout activities across all trial sites, the final dataset for the discontinued memantine, trazodone and contemporaneous placebo arms has now been locked. Whilst this data cleaning was underway, all researchers needed to remain blinded to participant's treatment allocation to reduce the risk of biasing the final dataset. As all the data gathered from these arms has now been cleaned, locked, and can no longer be amended, we are now in a position to unblind former trial participants (recruited to either memantine, trazodone, or contemporaneous placebo). 

Former trial participants recruited to either memantine, trazodone, or contemporaneous placebo who expressed a preference to be informed of their treatment allocation will be contacted by their local research team. 

If you are a relative of a former trial participant recruited to the above treatment arms (memantine, trazodone, or contemporaneous placebo) and wish to learn details of their treatment allocation, please contact the MND-SMART Trial office (mnd-smart@ed.ac.uk). 

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This article was published on: Monday, 9 December, 2024