Multiple Sclerosis - Secondary Progressive Multi-Arm Randomisation Trial
Multiple sclerosis (MS) is a disabling and progressive neurological disease that affects approximately 100,000 people in the UK. The secondary progressive (SPMS) stage of disease results not in individual attacks but slow, cumulative and irreversible disability affecting walking, balance, vision, cognition, pain control and bladder and bowel function. Critically, and unlike early disease, there is no proven treatment for the late stage of MS. This is therefore an urgent and major unmet health need.
MS-SMART will test 3 drugs (riluzole, amiloride and fluoxetine) in 440 people with SPMS. The drugs were selected from a group of medicines that are used to treat other conditions and show promising signs in the treatment of MS (in particular SPMS). Amiloride is used to treat heart disease, fluoxetine (depression) and riluzole (motor neurone disease).
It will take approximately one year to screen and recruit people into the trial. Participants will take one of the drugs OR a placebo pill (a dummy pill) for two years. No one will know which treatment they are taking while the trial in on-going. ‘Blinding’ as this is known is widely used in clinical trials and ensures the results of the trial are not subject to bias. During the trial participants will have a number of clinic assessments and Magnetic Resonance Imaging (MRI) scans.
Listed below is the MAIN criteria for taking part in the MS-SMART trial. A detailed screening process is required to make sure the trial is suitable and safe for someone to take part in.
-Secondary Progressive MS
-Not on DMT (Disease Modifying Treatment)
-Not taking a SSRI (Selective Serotonin Re-uptake Inhibitor), a type of anti-depressant
-Still able to walk at least 20 metres (with the support of 2 crutches) or up to 500 metres without help
-Aged 25-65 (inclusive)
Please note that MS-SMART is an academically led trial. It is not an international trial and recruitment can only take place in the UK.
How is MS-SMART funded? The MS-SMART trial is independent research awarded by the Efficacy and Mechanism Evaluation Programme (EME), a partnership between the Medical Research Council (MRC) and the National Institute for Health Research (NIHR), along with the Multiple Sclerosis Society (MS Society) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership. MS-SMART is an investigator led project sponsored by University College London (UCL). Additional support comes from the University of Edinburgh and the National Institute for Health Research University College London Hospitals Biomedical Research Centre. Sanofi is supporting the study by donating the supply of riluzole for the trial.
Please note, the team leading MS-SMART are not responsible for the accuracy of information about the trial provided on other sites, or by parties external to the MS-SMART researchers. The views expressed in this publication are those of the authors and not those of the MRC, NHS, NIHR, MS Society or the Department of Health.