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First assessment of individual RLS domains in new post-hoc analyses of Neupro® studies
Date:4/25/2012

001
  • Tiredness or sleepiness during the day: (-0.5 [-0.8, -0.3]); p<0.0001
  • Impact on ability to carry out daily affairs: (-0.6 [-0.8, -0.3); p<0.0001
  • Severity of mood disturbance: (-0.6 [-0.9, -0.4]); p<0.0001
  • Post-hoc analysis of the US study (SP792)

    In the post-hoc analysis of the US study improvements were observed with rotigotine versus placebo in 9 of 10 individual IRLS items as listed below:

    Core RLS symptoms

    • Discomfort in legs or arms (treatment difference [LS mean (95% confidence interval)]):  (-0.4 [-0.6, -0.2]), p=0.0009
    • Need to move around: (-0.5 [-0.7, -0.2]), p=0.0002
    • Relief of RLS discomfort by movement: (-0.4 [-0.6, -0.1]), p=0.0017
    • Severity of RLS as a whole: (-0.4 [-0.6, -0.2]), p=0.0003
    • Average severity when symptoms occurred: (-0.5 [-0.7, -0.2]), p<0.0001
    • Frequency of symptoms: (-0.9 [-1.2, -0.6]), p<0.0001

    Impact of RLS symptoms

    • Severity of sleep disturbance: (-0.4 [-0.6, -0.1]), p=0.0026
    • Tiredness or sleepiness during the day: (-0.3 [-0.5, -0.1]), p=0.0066
    • Impact on ability to carry out daily affairs: (-0.3 [-0.4, 0.1]), p=0.0021

    Improvements in 'severity of mood disturbance due to RLS symptoms' were numerically greater with rotigotine versus placebo but did not reach significance (-0.1 [-0.3, 0.0]), p=0.1536.

    Notes to Editors

    About Neupro® in the U.S.

    Neupro® (Rotigotine Transdermal System) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome (RLS). For more information about Neupro visit

    SOURCE UCB
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