The MS-SMART trial: an insider's perspective
Domenico completed his neurology training in 2014 during which he spent 6 months as a clinical fellow at University College London (UCL). He is now completing his PhD and is working as a Clinical Research Associate on the MS-SMART project. Despite his busy schedule he found time to give us an exclusive interview.
In a nutshell, what’s MS-SMART?
MS-SMART is a phase 2 clinical trial in progressive MS. It will test three different drugs that are already licensed for use in other conditions (repurposed), against one placebo to see if progression can be slowed. This multi-arm, repurposing approach potentially saves valuable time in trying to find a treatment for progressive MS. The three drugs we’re testing are:
- Amiloride - originally used to treat high blood pressure
- Riluzole - originally used in the management of motor neurone disease
- Fluoxetine - originally used in the management of depression
What’s your role in the trial?
I work at the National Hospital for Neurology & Neurosurgery at Queen Square in London, which is home to the UCL site of the study. I’m one of two Clinical Research Associates working closely together on this trial. One of us assesses an individual (firstly over the phone, then in the clinic) to determine whether they are suitable for the trial and monitors them throughout. The other carries out some clinical assessments to evaluate the patient at the start, during the treatment and at the end. No one will know which treatment the patients are taking while the trial is on-going. This prevents anyone having an influence on the results.
What’s involved for people taking part in the trial?
Initially participants are interviewed over the phone to check they are potentially eligible. They are then invited to the clinic for further assessment before enrolling on the study. 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, after 6 months and at the end). They also need to complete questionnaires and provide blood samples throughout.
Who do you want to get involved?
We are looking for 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 we 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. We cannot enrol anyone who has any significant co-morbidities (eg. Depression, glaucoma, epilepsy, malignancy), or is taking immunosuppressants, SSRIs or any disease modifying treatments.
Where’s the study taking place?
The two initial centres are at UCL (where I’m based), and in Edinburgh. We’re now as planned also recruiting at our other centres in: Brighton, Liverpool, Newcastle, Nottingham, Oxford, Plymouth, Sheffield, Stoke-on-Trent and Truro.
How’s your recruitment going so far?
It’s going well!
About 150 people have entered the trial in London and Edinburgh with no major issues. So we’re about a third of the way there. The first person to be enrolled in the study was recruited December 2014 and has been receiving treatment for about 6 months now.
When do you hope to finish recruiting?
We’ll be recruiting until the end of 2015. We need 440 people in total across all the sites for this study and our team at UCL are aiming to recruit 160 of these from London.
We’d like to say thanks to Domenico for a fascinating insight into the inner workings of a clinical trial.