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New Post Hoc Analyses Examined the Effects of Neupro® (Rotigotine Transdermal System) on Daytime Functioning, Daytime Symptoms, Pain and Mood in Restless Legs Syndrome

Fri, 06/10/2011 - 6:36am
Bio-Medicine.Org

BRUSSELS, June 10, 2011 /PRNewswire/ -- Results from new post hoc analyses assessing the effects of Neupro® (rotigotine transdermal system) in Restless Legs Syndrome (RLS) and utilizing novel surrogate markers suggested improved daytime functioning and daytime symptoms, reduced RLS-related pain and improved mood and depressive symptoms in patients with moderate to severe RLS. The data were presented at the 15th International Congress of Parkinson's disease and Movement disorders in Toronto, Canada.

Daytime functioning and daytime symptoms in RLS patients

RLS has been mainly associated with symptoms occurring in the late evening and at night. However, epidemiological studies and this post hoc analysis suggested that patients may also experience daytime symptoms and report impairment of daytime functioning.

Results of a post hoc analysis of a six month double blind study of rotigotine transdermal in 458 patients suggested improvement in daytime functioning and daytime symptoms in patients treated with rotigotine transdermal (1, 2 and 3 mg/24h, pooled data) than placebo.

"Daytime functioning symptoms, such as symptoms in the afternoon, sleepiness and tiredness due to bad sleep are a problem for many patients with moderate to severe RLS, and can adversely affect their ability to carry out everyday activities. While additional studies are needed, this post hoc analysis suggested that patients treated with rotigotine transdermal for 6 months may experience improvements in daytime functioning and daytime symptoms compared to those treated with placebo. These effects may be explained by the 24 hour coverage of symptoms, whenever they occur, with the application of transdermal rotigotine," said Dr. Ralf Kohnen, University of Erlangen-Nuremberg, Germany.

Significant improvements with rotigotine transdermal versus placebo (from baseline to end of maintenance) were seen in a series of measures of RLS symptom severity on the I

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