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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
Date:6/10/2011

nternational Restless Legs Syndrome Study Group Severity Rating Scale (IRLS) and the Restless Legs Syndrome-6 (RLS-6) scale, and quality of life on the Quality of Life Questionnaire for RLS patients (QoL-RLS):

Daytime functioning

  • QoL-RLS Item 6 "mood impairment due to daytime sleepiness": (p<0.0001)
  • IRLS Item 5 "severity of tiredness/sleepiness during the day due to RLS symptoms": (p<0.0001)
  • IRLS Item 9 "impact of RLS symptoms on ability to carry out daily affairs": (p<0.0001)
  • RLS-6 Item 6 "sleepiness/tiredness during the day": (p<0.0001)

Daytime symptoms

  • RLS-6 Item 4 "RLS symptom severity during the day at rest": (p<0.0001)
  • RLS-6 Item 5 "RLS symptom severity during the day when active": (p<0.0062)

Pain in RLS patients

Results of the post hoc analysis suggested that treatment with rotigotine transdermal (1, 2, and 3 mg/24 hours) for six months may improve impairment due to pain. More than half of the patients in the study experienced moderate to extreme impairment of daily activities due to pain at baseline.  Significant improvement with rotigotine transdermal versus placebo (from baseline to end of maintenance) was seen in the QoL-RLS Item 8 score, i.e. the degree to which pains in arms or legs impair wellbeing or normal daily activities  (p=0.0018).

Mood disturbance and depressive symptoms in RLS patients

Results of the post hoc analysis suggested that treatment with rotigotine transdermal (1, 2 and 3 mg/24 hours) for six months may improve mood disturbance and depressive symptoms.  Significant improvement with rotigotine transdermal versus placebo (from baseline to end of maintenance) was seen in the QoL-RLS Item 3, i.e. the degree to which RLS symptoms impair mental health/mood (p<0.0001) and in IRLS Item 10, i.e. the se
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