This study group used data from two phase III clinical trials of dalfampridine (fampridine outside the US) in 533 patients with MS and looked at the clinical meaningfulness of the Timed 25-Foot Walk (T25FW) changes. Walking speed (T25FWT) and patient-reported walking ability (MS Walking Scale-12 (MSWS-12)) were measured.
The researchers examined T25FWT speed variability within and between visits, correlations of T25FWT speed with MSWS-12 score and changes in MSWS-12 associated with percent T25FWT changes. They found correlations between T25FWT and MSWS-12 values were low, but stronger between their change values.
Improvements in speed of >20%, and possibly of >15%, were associated with clinical meaningful changes in self-reported walking ability using MSWS-12 change score and effect size criteria. Therefore, this study shows direct evidence that improvements in T25FWT speed of >20% are meaningful to MS patients and supports the T25FWT as a clinical meaningful outcome measure for MS clinical trials.
Authors: Hobart J, Blight AR, Goodman A
Source: Neurology. 2013 Mar 27. [Epub ahead of print]
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