The MS-SMART trial is closed - here is what taking part in the trial involved
Tablets containing one of the drugs being tested or a dummy pill were taken every day for 2 years. The effects of treatment were measured by:
· Assessments at clinic visits (approximately 8 in year 1 and approximately 2 in year 2).
· A number of questionnaires completed at certain clinic visits.
· Blood samples at each clinic visit to monitor safety.
· At some centres participants were invited to take part in additional sub-studies (participation in any of the sub-studies is optional).
· Participants had 3 MRIs during the trial, before treatment started, at 6 months and at 2 years at the end of the trial.
Everyone who takes part in a clinical trial needs to meet the eligibility criteria, a defined set of rules which state who is suitable to join the trial. The eligibility criteria ensures the trial recruits people who may benefit from the treatment being tested and provides a safeguard so that people who may be at risk if they take part are not recruited.
A screening process took place to ensure the eligibility criteria was met. Screening was made up of several stages. It was very detailed and some stages of the screening process took place at a clinic visit. The medical teams knew only once the full screening process had taken place whether the trial was suitable for someone and at that point invited them to participate in the trial.
The MAIN criteria for taking part in the MS-SMART trial was:
-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)
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.