Staff neurologist, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic
The Cleveland Clinic neurologist explained how the combination of the SDMT and EDSS measurements could improve the phase 3 clinical trial landscape in multiple sclerosis.
“When we combine the Symbol Digit Modalities Test and the EDSS, we can get a more robust, and thereby sensitive, measure of disability progression [in progressive MS].”
In a conversation with NeurologyLive® on the floor at the 2019 American Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania, Robert Fox, MD, pointed out one of the challenges in conducting later stage clinical trials in progressive multiple sclerosis: measuring disease progression.
The staff neurologist at Cleveland Clinic’s Mellen Center for MS detailed that over the last few decades, the standard in trials of MS therapies has been to use the Expanded Disability Status Scale (EDSS) score, which has been helpful in showing therapeutic efficacy, but lacks some of the sensitivity that neurologists and MS specialists would hope to see. Additionally, as the scale goes along, the focus shifts mainly toward ambulation, despite the myriad symptoms that patients with MS face.
To explore if a cognitive measure could be added to the EDSS to improve this sensitivity, Fox and colleagues took a phase 3 dataset from siponimod’s (Mayzent, Novartis) developmental program and assessed the response metrics. They chose the Symbol Digit Modalities Test (SDMT), as it has shown excellent sensitivity in detecting the presence of brain damage and changes in cognitive functioning over time in conditions such as mild cognitive impairment (MCI).
Fox discussed these findings with NeurologyLive®, and explained how the combination of these measurements could improve the phase 3 clinical trial landscape in MS.
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Benedict R, Fox R, Tomic D, et al. Effect of Siponimod on Cognition in Patients with Secondary Progressive Multiple Sclerosis (SPMS): Phase 3 EXPAND Study Subgroup Analysis. Presented at: 2019 American Academy of Neurology Annual Meeting. May 4-10, 2019; Philadelphia, PA.