- Data Presented at the 132nd Annual Meeting of the American Neurological
Association in Washington, D.C. -
ATLANTA, Oct. 8 /PRNewswire/ -- UCB, Inc. presented results from two Phase III pivotal trials and one open-label extension trial of rotigotine transdermal system for the treatment of moderate-to-severe restless legs syndrome (RLS). These rotigotine data showed significant drops in RLS symptoms, including changes of up to 8 points over placebo using the International Restless Legs Syndrome Study Group Rating Scale (IRLS) and a reduction in disease severity over a two-year period.
"Given the strong efficacy and tolerability seen to date, rotigotine, if approved, would provide a new and valuable alternative for many patients negatively impacted by the symptoms of moderate-to-severe RLS," said Wayne Hening, M.D., a lead study investigator and Assistant Clinical Professor of Neurology at the Robert Wood Johnson Medical School.
In the two six-month, double-blind, placebo-controlled trials, rotigotine produced clinically relevant and statistically significant reductions in RLS symptoms compared to placebo and was generally well-tolerated. An additional presentation highlighted a two-year interim analysis of a long-term, open- label extension of rotigotine for moderate-to-severe RLS, representing some of the longest safety follow-up information for a dopamine agonist in RLS to date.
In these studies, the efficacy of rotigotine was evaluated by
monitoring several clinician-administered scales including the IRLS, the
Clinical Global Impressions (CGI) and the Restless Leg Syndrome-6 (RLS-6).
The IRLS scale measures the severity and frequency of RLS symptoms and the
degree to which they affect sleep and daily life (IRLS: 0 = no symptoms and
40 = very severe symptoms). The CGI scale measures the general severity of
an illness, clinical improvement or efficacy of treatment parameters. On
the RLS-6 scale, patients rate the
|SOURCE UCB, Inc.|
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