Rotigotine Transdermal System Shows Significant Symptom Reduction and Tolerability in Patients with Restless Leg...(severity of their RLS at four periodsdur...),Health

A synopsis of rotigotine RLS clinical data presented at the meeting follows.

Six-Month Studies in Patients with Moderate-to-Severe Idiopathic RLS

SP 790

* In a multi-center, double-blind, placebo-controlled, Phase III trial,

458 patients were studied in eight European countries

* Rotigotine was studied in doses of 1, 2 and 3 mg/24 hours over a period

of six months

* The study showed a statistically significant improvement in the IRLS sum

score and a clinically relevant reduction in the CGI Item-1 (severity of

illness) score compared to placebo

* The mean baseline scores were: IRLS 28.1 plus or minus 6.1 and CGI 5.0

plus or minus 0.8 reflecting moderate-to-severe symptoms at baseline

* The net effects over placebo after 6 months of treatment were -5.1 plus

or minus 1.3, -7.5 plus or minus 1.3, and -8.2 plus or minus 1.3 in the

IRLS and -0.76 plus or minus 0.19, -1.07 plus or minus 0.19 and -1.21

plus or minus 0.19 in CGI Item-1 for rotigotine 1, 2, and 3 mg/24 hours

respectively (p < 0.001 for all comparisons)

* Rotigotine was also shown to be generally well-tolerated

* The most common adverse events that were determined by the investigators

to be drug-related were application site reactions, nausea, headache and

dizziness

SP 792

* In a multi-center, double-blind, placebo-controlled, Phase III trial,

505 patients were studied in the United States

* Rotigotine was studied at doses of 0.5, 1, 2 and 3 mg/24 hours over a

period of six months, with all doses showing improvement over placebo

* Rotigotine, in doses of 2 and 3 mg/24 hours over a period of six months,

resulted in a statistically significant improvement in IRLS sum score

and a clini
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