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New Data Show Low Incidence of Augmentation of Restless Legs Syndrome With 5-Year Neupro® (rotigotine) Treatment
Date:4/14/2011

mg/24h) and periodically evaluated for safety and efficacy.  Of the 295 patients in the study, 126 completed the 5-year follow-up.

Rotigotine showed an improvement in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from 27.8 + or - 5.9 at baseline to 9.0 + or - 9.2 after 5 years. Computer screening identified 145 patients out of 295 (49.2%) with potential augmentation and this was confirmed in 69 patients (24.3%), according to the Max Planck Institute (MPI) diagnostic criteria for augmentation. An international panel confirmed that 39 patients (13.2%) had clinically significant augmentation. Of all patients with clinically significant augmentation, 61.5% were on the highest, unapproved dose of rotigotine (4 mg/24h *) and 61.5% experienced their first episode after one year. Frequency of newly diagnosed augmentation decreased over time, and new episodes were more frequently clinically significant. Study discontinuation due to augmentation occurred in 12 cases (4.1%).

* Neupro® (rotigotine) 0.5 mg/24h and 4mg/24h dose are not approved doses in the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.

Notes to Editors

About Restless Legs Syndrome

Restless Legs Syndrome (RLS) is a neurological disorder characterized by unpleasant sensations in the legs and an uncontrollable urge to move when at rest in order to relieve these feelings. It effects between 3 and 10% of the population to some extent. Most people with RLS have difficulty falling asleep and staying asleep. Left untreated the condition causes exhaustion and daytime fatigue. Many people with RLS report that their job, personal relations and activities of daily living are strongly affected as a result of their exhaustion. They are often unable to concentrate, h
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