Research Triangle Park, NC (December 15, 2004) Study results published today in the journal Movement Disorders show that Requip(ropinirole HCl) Tablets effectively treats the symptoms of primary Restless Legs Syndrome (RLS) as assessed by improvements in symptoms, over 12 weeks. Improvements were seen as early as one week. The study of 267 patients, one of the largest placebo-controlled trials of a treatment for RLS conducted to-date, also showed significant improvements in sleep and quality of life in RLS patients taking Requip versus placebo. Requip is under review by the U.S. Food and Drug Administration (FDA) for the treatment of the signs and symptoms of primary RLS. There is no FDA-approved treatment for RLS in the United States.
"Patients with Restless Legs Syndrome often suffer from chronic sleep problems as a result of an urge to move their legs, often accompanied by discomfort or unpleasant feelings in their legs. This sleep disruption is one of the most distressing aspects of the condition and can greatly impact quality of life," said Arthur S. Walters, M.D., Director of the Center for Sleep Disorders Treatment, Research and Education at the New Jersey Neuroscience Institute at John F. Kennedy Medical Center. "These study results are encouraging because they provide evidence that Requip significantly improved symptoms of RLS at one week. Patients experienced improvements in sleep and quality of life."
Restless Legs Syndrome is a common and disruptive neurological condition characterized by an irresistible urge to move the legs and by uncomfortable or sometimes painful sensations in the legs often described as creeping-crawling, burning or twitching. Symptoms of RLS generally occur at rest, such as when sitting, lying or sleeping, and are temporarily relieved by movement. These symptoms can significantly disrupt a patient's sleep and daily activities. People with RLS often have difficulty falling and staying asleep and can feel
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Contact: Christina Corso
christina_corso@nyc.cohnwolfe.com
212-798-9511
Cohn & Wolfe
15-Dec-2004
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