Use of the Multiple Sclerosis Functional Composite as an Outcome Measure in a Phase 3 Clinical Trial

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Abstract
TO ADDRESS THE poor reliability and insensitivity to change over time of the available multiple sclerosis (MS) clinical rating scales, including the Kurtzke Expanded Disability Status Scale (EDSS),1 the National MS Society's Clinical Assessment Task Force (NMSS Task Force) developed the MS Functional Composite (MSFC).2-5 The MSFC includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk [T25FW]), arm function (9-Hole Peg Test [9HPT]), and cognitive function (Paced Auditory Serial Addition Test [PASAT]). Although vision was recognized as an important clinical dimension in MS, the measures of visual function for which longitudinal data were available were found not to be sufficiently sensitive to change to include in the initial version of the MSFC. In recent studies,6 contrast sensitivity showed promise as a measure of visual function for potential inclusion in the MSFC.