Rotigotine Transdermal System Shows Significant Symptom Reduction and Tolerability in Patients with Restless Leg...(cally relevant reduction in the CGI Item...),Health

illness) score compared to placebo

* The mean baseline scores were: IRLS 23.3 plus or minus 5.0 and CGI 4.7

plus or minus 0.7, reflecting moderate-to-severe symptoms at baseline

* The net effects over placebo after six months of treatment were -2.2

plus or minus 1.2, -2.3 plus or minus 1.2, -4.5 plus or minus 1.2

(p<0.001), -5.2 plus or minus 1.2 (p<0.001) in the IRLS and -0.35 plus

or minus 0.19, -0.32 plus or minus 0.19, -0.65 plus or minus 0.19

(p<0.001), -0.90 plus or minus 0.19 (p<0.001) in CGI Item-1 for

rotigotine 0.5, 1, 2, and 3 mg/24 hours respectively

* Rotigotine was also shown to be generally well-tolerated

* The most common adverse events were application site reactions (27.2%),

nausea (21.5%), headache (17.6%) and somnolence (12.6%)

24-Month, Open-Label Extension Trial in RLS

SP 710

* In an open-label extension of a double-blind, placebo-controlled, Phase

II dose-finding study conducted at multiple centers in Europe,

rotigotine, administered with optimal dose titration, showed long-term

therapeutic efficacy in patients with moderate-to-severe idiopathic RLS

who were treated for 24 months

* A total of 295 patients entered the open-label extension trial and 191

(65%) completed the two-year maintenance period of this ongoing trial

* After 24 months of open-label rotigotine treatment, 87% of patients were

rated as only mildly ill, borderline symptomatic, or normal on the CGI

Item-1 scale which rates overall severity of illness

* The "change of condition" CGI Item-2 score showed a sustained

improvement from the beginning through to the 24th month of open-label

maintenance

* Additionally, the "severity at bedtime falling asleep" score (RLS-6 Item

2) improved by 4.0 plus or minus 3.1 p
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