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

of leg or arm discomfort from moving around
  • Item 4: severity of sleep disturbance due to RLS symptoms
  • Item 5: tiredness or sleepiness during the day due to RLS symptoms
  • Item 6: severity of RLS as a whole
  • Item 7: frequency of RLS symptoms
  • Item 8: average severity when RLS symptoms occurred
  • Item 9: impact on ability to carry out daily affairs
  • Item 10: severity of mood disturbance due to RLS symptoms
  • In these post-hoc analyses, the severity and impact of RLS symptoms were analysed using mean change from baseline to end of maintenance in individual IRLS item scores. Results presented below should be viewed in the context of the post-hoc analyses. In addition the p-values reported are exploratory and additional prospective studies are needed to further our understanding in this area.

    Post-hoc analysis of the European study (SP790)

    In the post-hoc analysis of the European 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)]:  -0.8 [-1.1, -0.6]); p<0.0001
    • Need to move around: (-0.8 [-1.1,-0.5]); p<0.0001
    • Severity of RLS as a whole: (-0.8 [-1.1, -0.6]); p<0.0001
    • Average severity when symptoms occurred: (-0.7 [-1.0, -0.5]); p<0.0001
    • Frequency of symptoms: (-1.0 [-1.3, -0.6]); p<0.0001

    Improvements in relief of 'RLS discomfort by movement' were numerically greater with rotigotine transdermal system versus placebo but did not reach significance (-0.1 [-0.3, 0.0], p=0.1216.

    Impact of RLS symptoms

    • Severity of sleep disturbance: (-0.9 [-1.1, -0.6]); p<0.0
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    SOURCE UCB
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