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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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