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Participant information

Participant information

If you're thinking of taking part in the trial, here is some additional information about what is involved.

This clinical trial is testing how effective two different drugs are at slowing down the progression of motor neurone disease (MND). These drugs are already approved to treat other medical conditions.

If you take part in the trial, you will be given one of two active drugs or a dummy drug (placebo). You will be asked to take the medicine once a day. It will be in a liquid form.

During the trial we will review how well the medicines are working 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. This is known as an ‘adaptive trial’. 

During the trial, neither you nor the doctor or nurse treating you will know which medicine you are taking. This is to make sure that the results of the trial are unbiased.

Tests

During the trial you will be asked to take part in regular tests and assessments. These will  include:
  • blood tests
  • an ECG (a routine heart trace)
  • breathing assessments
  • questionnaires about physical functioning, your mental health and your MND
  • cognitive assessments (memory, problem solving etc)

Clinic visits and follow up

You will need to attend appointments to take part in the tests and assessments. Some of these will be at your nearest trial centre and some can be completed over the telephone or using secure videoconferencing. The research team will discuss with you where your ‘in clinic’ appointment will be.
 
We can help you with travel costs. Please speak to one of the research team about this.

Side effects

All of the medicines we are testing have already been approved and are currently used to treat other medical conditions in the UK. We will tell you about any common side effects and explain to you about any other risks we think there might be to anyone taking part in the trial.

Who can take part?

To take part in the trial you must be:
  • diagnosed with MND
  • over the age of 18
  • living in the UK
  • not pregnant or breastfeeding
There will also be additional screening to ensure that any other medicines you are taking will not interfere with the trial drugs. You can’t take part if you are taking part in another clinical trial.

Do I have to take part?

No. It is up to you if you want to take part in the trial or not. If you do take part, you are free to stop taking part in the trial at any time.
 
Please note: This is a summary information about the trial. You must read the full Participant Information Sheet, given to you by the trial team, before you take part in this trial.

 

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