What is MND SMART?

MND SMART (Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial) is the UK's first 'multi-arm' trial. This means more than one treatment will be tested 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.

New drugs will be selected for investigation in MND-SMART based on continuous review of constantly updated scientific evidence as well as findings from state-of-the-art human stem cell based drug discovery platforms. Find out more on the MND Clinical Studies Group website or on clinicaltrials.gov. 

Which drugs are currently being tested?

Amantadine Hydrochloride

Current status: Open for recruitment

What is the drug thought to do in the body?

Amantadine Hydrochloride is a drug which is already use in the management of Parkinson’s disease, treatment of fatigue in MS and as an antiviral medicine in the treatment of Type A influenza. It has a number of mechanisms of actions including boosting dopamine activity and reducing glutamate. In MND, it is thought that over activity of glutamate can be toxic and cause cells to die. Dopamine is an important neurotransmitter involved in motor control and neuron signaling.

 

Trial Information

Recruiting Sites

The trial is currently recruiting in the UK at the following sites:

  • Edinburgh
  • Dundee
  • Glasgow
  • Salford
  • Aberdeen
  • Inverness
  • Southampton
  • Exeter
  • Norfolk
  • St George's London
  • West Suffolk
  • Birmingham
  • Ipswich
  • Newcastle
  • Cambridge
  • Barts/Royal London
  • Craigavon, Northern Ireland
  • Poole
  • Cardiff
  • Sheffield
  • Brighton
  • Kings College London

Find out more about recruiting sites and register your interest to take part here.

Trial Information

Phase: Phase 2/3 - this means that if the drugs appear to be effective, they will seamlessly transition into a phase 3 trial.

Placebo Controlled: Yes - this means that people joining the trial could be randomly assigned to receive the placebo (dummy drug). 

Open-Label Extension: No - this means that participants will only receive either the treatment or the placebo throughout the trial. However, if a drug is found to not be beneficial, participants may have the opportunity to re-enter the trial. However, participants will still be randomly assigned either the treatment or placebo. 

Trial Results

Memantine Hydrochloride

What is the drug thought to do in the body? 

In MND, a neurotransmitter called glutamate, which helps nerve cells communicate, has been shown to be over-active. This is thought to be toxic to nerve cells. Memantine aims to reduce the action of glutamate. 

Outcome

The memantine arm was ended early after the trail was evaluated as part of the regular interim analyses. At the stage 2 interim analysis, it was found that memantine was highly unlikely to be beneficial for people living with MND. This was shown by no significant improvement in the rate of change in the ALSFRS-R scale compared to the placebo – indicating no change in the rate of progression of the disease. 

Trazodone Hydrochloride

What is the drug thought to do in the body? 

In MND, proteins (which are vital for all the tasks in a cell) have been shown become faulty and form toxic clumps. Trazadone aims to reduce the production of faulty proteins. 

Outcome

The trazodone arm was ended early after the trail was evaluated as part of the regular interim analyses. At the stage 2 interim analysis, it was found that trazodone was highly unlikely to be beneficial for people living with MND. This was shown by no significant improvement in the rate of change in the ALSFRS-R scale compared to the placebo – indicating no change in the rate of progression of the disease. 

Latest News

2023

September 2023 - The independent trial committee decided testing should not continue for trazadone and memantine as it was highly unlikely either drug would show people for people with MND. It was also announced that 3 new drugs will be added to the trial in 2024/2025.  

April 2023  - A new drug was added to MND SMART, called Amantadine Hydrochloride.

2022

April 2022 - An independent review concluded that testing for both current drugs (Memantine and Trazodone) should be continued. Find out more. 

 

Jan 2022  - Over 260 participants have been recruited from 16 sites across the UK.

Last updated: 21/08/2024