Can cladribine slow worsening of arm and hand function in people with advanced progressive MS?
- Lead researcher:
- Professor Klaus Schmierer
- Based at:
- Queen Mary University of London & Barts NHS Health Trust
- MS Society funding:
- £370,000. Total cost: £3,672,771. Trial funded by the Efficacy & Mechanism Evaluation Programme (a partnership between the National Institute for Health Research & Medical Research Council), Merck Serono, Barts’ Charity, National MS Society and ourselves.
There are currently no disease modifying therapies available for people with MS who can’t use their lower limbs at all or can only walk short distances with the help of aids like crutches.
This new phase 2 trial will test whether cladribine, a drug already licensed for highly active relapsing MS, can help people with MS maintain the use of their arms and hands.
Cladribine targets immune activity in the brain. Traditionally, it was thought this type of treatment wouldn’t be effective in more advanced MS. But recent evidence suggests it may still be effective at this stage.
What happens in this project?
ChariotMS will recruit 200 people who have an EDSS (Expanded Disability Status Scale) score of 6.5 to 8.5. This means they can’t walk further than 20 meters with two crutches or are unable to walk at all, but still have at least some use of their arms and hands. For more information please email the trial team at [email protected]
Eligible participants will be randomly assigned to take either cladribine or a placebo (dummy drug) that they will take as a tablet over the course of 24 months. There will be 20 trial sites around the UK, including locations in London, Belfast, Cardiff and Edinburgh.
To work out whether the drug is effective, the researchers will use a test of arm and hand function called the nine hole peg test. They will also be collecting MRI scans of participants to see whether cladribine shows an effect on lesions in the brain.
How will it help people with MS?
Thanks to research, there are over a dozen licensed disease modifying therapies for people with relapsing MS, and some emerging for early progressive MS.
But traditionally, clinical trials for MS have not included people who are dependent on a wheelchair to get around. And drugs have only been licensed if they improve walking ability.
ChariotMS will allow some people who have never before been eligible for a clinical trial to take part in one. And if cladribine is shown to slow the worsening of disability for people with advanced MS, it could mean this group of people will eventually have access to a treatment for the first time.
The difference you can make
The race is on to find treatments that will slow or even stop disability progression in MS. You can help speed up the process by supporting projects like this.