MS-SMART has started and recruitment into the trial will continue through 2015. Two centres are currently open and all centres taking part will be open soon.
Multiple Sclerosis (MS) is a disabling and progressive neurological disease that affects approximately 100,000 people in the UK. The Secondary Progressive (SPMS) type of disease causes 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 is a phase 2 clinical trial in people with Secondary Progressive MS, which has been part-funded by the MS-Society. It is testing three different drugs (Amiloride, Riluzole and Fluoxetine) against a placebo (dummy drug) to see if they can slow the worsening of disability. Read more about MS-SMART on the MS Society website: http://bit.ly/1Mv8N1M
The trial is looking to recruit participants for its London centre at the National Hospital for Neurology & Neurosurgery at Queen Square, as well as other sites in Edinburgh, Brighton, Liverpool, Newcastle, Nottingham, Oxford, Plymouth, Sheffield, Stoke-on-Trent and Truro.
Recruitment for the trial will continue until the end of spring 2016. The trial needs 440 people in total across all the sites for this study and the team at UCL are aiming to recruit 160 of these from London. They need another 50 or so!
Initially participants are interviewed over the phone to check whether they are eligible. They are then invited to the clinic for further assessment before enrolling on the study. In total the trial involves around 11 visits to the clinic: 8 in the first year and 3 in the second. During the 2 year study, participants undergo three MRIs (One at the beginning, 6 months later and at the end). Also, they need to complete questionnaires and provide blood samples throughout.
Who is eligible for the trial?
The trial is recruiting people between the ages of 25 and 65 (inclusive) with a confirmed Secondary Progressive diagnosis and steady progression in disability. More specifically, people with an Expanded Disability Status Scale (EDSS) of 4-6.5. This means that the researchers can enrol patients who are still able to walk at least 20 metres (with the support of 2 crutches) or up to 500 metres without help. Unfortunately, they cannot enrol anyone who has any significant co-morbidities (E.g. Depression, glaucoma, epilepsy, malignancy), or is taking Immunosuppressants, SSRIs (E.g. Citalopram) or any disease modifying treatments.
How to find out more..
If you’re interested in taking part, either email: firstname.lastname@example.org or call 07572898453. Visit the MS-Smart website: http://bit.ly/1Mv8N1M
Hear from London based neurologist Dr Domenico Plantone, who is working closely on the trial as a Clinical Research Associate.
You can also visit the MS-SMART website to sign up or find out more. Recruitment for the trial will continue until the end of spring 2016. The trial needs 440 people in total across all the sites for this study and the team at UCL are aiming to recruit 160 of these from London. They need another 50 or so!