UCB today announced the results of a 6-month, randomized, double-blind, placebo-controlled clinical study, published in the journal Movement Disorders, showing that Neupro® (rotigotine transdermal system, 2 and 3 mg/24 hours) provided sustained, clinically relevant improvements in symptoms of Restless Legs Syndrome (RLS). The study also showed high rates of complete remission seen with rotigotine 2 mg or 3 mg/24 hours.
“In this study rotigotine alleviated RLS symptoms in patients with moderate to severe RLS over a treatment period of six months, which is the longest reported double-blind treatment period maintained in the U.S. for the evaluation of RLS treatments,” said Dr. Richard Allen, from Department of Neurology, John Hopkins University, Baltimore, Md., U.S. “One result from this study was a high rate of complete remission from all RLS symptoms. Approximately one of three previously moderately to severely ill patients was without any RLS symptoms after 6 months of treatment with either 2 or 3 mg of rotigotine.”
In the 6-month, double-blind study, 505 patients with moderate to severe RLS were randomized to receive either placebo or rotigotine (0.5, 1, 2, 3 mg/24 hours) by transdermal administration, of whom 494 patients (98%) were included in the modified intention-to-treat (mITT) analysis. The two co-primary efficacy endpoints were decreased from baseline to end of maintenance in International Restless Legs Syndrome (IRLS) sum score and in Clinical Global Impressions (CGI-1) score. The IRLS sum score ranges from 0 (no symptoms) to 40 (very severe symptoms) and the CGI-1 from 1 (not ill at all) to 7 (extremely ill). Secondary efficacy variables included the proportion of treatment responders for IRLS and CGI-1.