First MS clinical trial with focus on people who cannot walk
The first multiple sclerosis (MS) clinical trial focusing only on people who cannot walk will start recruiting participants next year.
The ChariotMS study will test whether cladribine tablets (Mavenclad), which is already licensed for highly active relapsing MS, can slow the rate of upper limb disability progression in people with advanced MS.
People who are reliant on a wheelchair have so far not been included in clinical trials for MS and drugs have only been licensed if they improve walking ability.
According to the MS Society charity, 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, the study could lead to the first MS drug licensed that protects upper limb function.
Professor Klaus Schmierer, from Queen Mary University of London and Barts Health NHS Trust, is leading the trial.
He 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.”
From January 2021, ChariotMS will recruit 200 people with MS who can walk only a short distance with two crutches or are unable to walk at all but retain some upper limb function.
The trial has no upper age limit.
Dr Emma Gray, assistant director of research at the MS Society, said: “More than 130,000 people live with MS in the UK, and those with more advanced forms can experience difficulty with walking, relying on mobility aids like walking sticks and wheelchairs to help.
“But as MS progresses, many go on to experience problems with their hand and arm function too – and treatment options start to disappear.
“Preserving hand and arm function would unquestionably improve the quality of life of people with MS, helping them to live more independent lives.
“That’s why we’re so thrilled to help make this important trial a reality.”
The trial is funded by the Efficacy and Mechanism Evaluation Programme, which is a partnership between the Medical Research Council and National Institute for Health Research.
It will receive additional funding from the MS Society, the National MS Society USA, Barts Charity, and Merck Serono.