The first multiple sclerosis (MS) clinical trial to focus only on people in a wheelchair is to start recruiting at Barts Health NHS Trust.
The trial, called ChariotMS, is being run from The Royal London Hospital, and will test whether cladribine tablets, already licensed for certain forms of MS, can slow the rate of upper limb disability progression in people with advanced forms of the condition.
From January 2021, ChariotMS will recruit 200 people with MS across 20 UK centres who can walk only a short distance with two crutches, or are unable to walk at all but retain some upper limb function. ChariotMS is also the first trial with no upper age limit.
Until now, clinical trials for MS have not included people who are reliant on a wheelchair, and in turn, maintaining their upper limb function. The main reason for this is was understood that treatment would not be beneficial given the nature of the condition in these individuals. This means that to date, drugs have only been licensed if they improve walking ability.
This means there are currently no disease modifying therapies (DMTs) available for the 35-40% of people with MS who need significant help walking. If successful, this trial could change that and lead to the first MS drug licensed that protects upper limb function, which is essential for those reliant on using a wheelchair.
MS is a condition that can affect the brain and spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance.
It's a lifelong condition that can sometimes cause serious disability, although it can occasionally be mild. There are two forms of the disease: relapsing MS, for which there are over a dozen licensed DMTs, including cladribine, and progressive MS, for which only two DMTs are available.
Cladribine tablets are a highly effective treatment for people with relapsing MS and early data suggest the drug could also be effective in those with advanced MS.
Participants in the ChariotMS trial will be randomised into a treatment arm and a placebo control arm. The treatment group will receive cladribine tablets for two years and the placebo group will receive ‘dummy’ tablets for the same length of time.
Upper limb function will be assessed by the 9-hole peg test (9HPT). The test, which is the standard way of measuring upper limb function, requires individuals to remove and place nine pegs on a board as quickly as possible. Participants 9HPT response will be assessed at every visit and then every six months until trial completion to monitor and measure any change and progress in response time.
Professor Klaus Schmierer, a consultant neurologist at The Royal London Hospital and the clinical and research lead for BartsMS, is leading on the trial.
Klaus, also a professor of neurology at the Blizzard Institute at Queen Mary University of London, said:
“Finding ways to maintain people’s upper limb function is essential to their quality of life, but until now walking ability has been the only official measurement of whether or not an MS treatment is effective.
“This has excluded people who depend on a wheelchair from taking part in trials and, as a result, from accessing effective treatment that will help maintain their hand and arm function.”
The trial is being funded by Barts Charity and the Efficacy and Evaluation Mechanism Programme, a partnership between the Medical Research Council and National Institute for Health Research.