Responsiveness of the Scripps neurologic rating scale during a multiple sclerosis clinical trial

Objective: The Scripps neurologic rating scale (SNRS) is a summary measure of individual components comprising a neurological examination, designed fo r use in multiple sclerosis (MS). Our objective is to evaluate the responsi veness of the SNRS, within the context of a 2-year, randomized, double-blin d crossover study of the efficacy of cladribine for treatment of secondary progressive MS. Methods: Effect sizes were determined for the SNRS and its components, separately for each treatment group (initial placebo, and initi al cladribine) over both years of the clinical trial, using a standard rand om effects model. Results: Individual components tended to show positive ef fect sizes (improvement) during periods of active therapy in both treatment groups, and negative effect sizes (deterioration) during periods of no act ive therapy. Summation indices derived from the individual components of th e SNRS seemed somewhat more stable than the individual components. The two components mentation and mood, and bladder, bowel, or sexual dysfunction, w ere rather unresponsive in our clinical trial. Conclusions: Changes in the components of the SNRS over the course of our clinical trial were consisten t between the two treatment groups. Most components were moderately respons ive; and, the summary SNRS score appropriately summarized the moderate magn itudes of change evinced in the individual components.