Neurology
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Multicenter Study Comparative Study Controlled Clinical Trial
Sample sizes for brain atrophy outcomes in trials for secondary progressive multiple sclerosis.
Progressive brain atrophy in multiple sclerosis (MS) may reflect neuroaxonal and myelin loss and MRI measures of brain tissue loss are used as outcome measures in MS treatment trials. This study investigated sample sizes required to demonstrate reduction of brain atrophy using three outcome measures in a parallel group, placebo-controlled trial for secondary progressive MS (SPMS). ⋯ SIENA and central cerebral volume are feasible outcome measures for inclusion in placebo-controlled trials in secondary progressive multiple sclerosis.
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Randomized Controlled Trial Multicenter Study
Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS.
To assess the efficacy and tolerability of the nondopaminergic agent XP13512/GSK1838262 in adults with moderate to severe primary restless legs syndrome (RLS). ⋯ XP13512 1,200 mg, taken once daily, significantly improved restless legs syndrome (RLS) symptoms compared with placebo and was generally well tolerated in adults with moderate to severe primary RLS.