An upcoming Phase 2 clinical trial, called ChariotMS, will test whether Mavenclad (cladribine) can slow a worsening of hand and arm function in people with progressive multiple sclerosis (MS) and very limited walking abilities.
Patients reliant on wheelchairs or aids to walk even short distances generally have advanced disease, often marked by progression to secondary progressive MS and scores of 6.5 or above on the Expanded Disability Status Scale (EDSS). Advanced patients are typically not included in MS clinical trials, in part because they can use walking ability as a key measure of effectiveness when testing potential disease-modifying therapies (DMTs).
“Finding ways to maintain people’s upper limb function is essential to their quality of life,” Klaus Schmierer, PhD, of Queen Mary University of London and Barts Health NHS Trust, said in a press release.
But trials can exclude “people who depend on a wheelchair from taking part … and, as a result, from accessing effective treatment that will help maintain their hand and arm function,” added Schmierer, who is leading the upcoming study.
Most DMTs today are approved for relapsing-remitting MS, the disease’s most common form.
Rather than focusing on changes in walking ability as an efficacy determinant, ChariotMS will use the Nine Hole Peg Test, a measurement of hand and arm function. Enrolled patients will also undergo MRI scans to assess the treatment’s effect on brain lesions.
The U.K. trial aims to recruit 200 people with EDSS scores between 6.5 and 8.5, meaning they cannot walk more than 20 meters (about 65 feet) using two crutches, or are completely unable to walk. All eligible patients will still retain some function in their arms and hands.
As such, it is open to people with advanced and progressive disease, regardless of whether their MS is primary progressive (PPMS) or secondary progressive (SPMS), without any upper age limit. Patients will be randomly assigned to either Mavenclad or placebo tablets over the study’s 24 months.
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