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 severity of their RLS at four periods during the night and day, as well as sleep satisfaction and daytime tiredness.

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 В± 6.1 and CGI 5.0 В± 0.8 reflecting moderate-to-severe symptoms at baseline

- The net effects over placebo after 6 months of treatment were 5.1 В± 1.3, -7.5 В± 1.3, and -8.2 В± 1.3 in the IRLS and -0.76 В± 0.19, -1.07 В± 0.19 and -1.21 В± 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 clinically relevant reduction in the CGI Item-1 (severity of illness) score compared to placebo

- The mean baseline scores were: IRLS 23.3 В± 5.0 and CGI 4.7 В± 0.7, reflecting moderate-to-severe symptoms at baseline

- The net effects over placebo after six months of treatment were -2.2 В± 1.2, 2.3 В± 1.2, -4.5 В± 1.2 (p