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GSK'S Requip(R) (ropinirole HCl) significantly reduces periodic leg movements in patients with RLS

Philadelphia, PA (August 1, 2004) New data published in the August issue of SLEEP shows that patients with primary Restless Legs Syndrome (RLS) and with periodic leg movements during sleep (PLMS), have fewer awakenings resulting from involuntary kicks when treated with GlaxoSmithKline's Requip (ropinirole HCl). Patients also reported better sleep adequacy as defined by feeling rested upon waking in the morning. Objective measurements showed that PLMS significantly decreased from nearly 49 per hour to 12 per hour in the group treated with Requip compared to a decrease of 36 per hour to 34 per hour in the placebo group (P < 0.0001). In the study, patients treated with Requip also experienced a significant reduction in the number of times PLMS woke them from sleep, termed PLMA (PLM with arousal), from 7 per hour to 2.5 per hour (p = 0.0096). Requip is under review by the U.S. Food and Drug Administration (FDA) for the treatment of RLS. There is no currently approved treatment for RLS in the United States.

"The RLS patients in our study suffered from involuntary movements of their legs that often disrupted their sleep. These leg movements are often associated with RLS," stated Clete A. Kushida, M.D., Director of the Stanford University Center for Human Sleep Research and an author of the study. "These new study results show that patients who were given Requip had significant reductions in the number of leg movements, resulting in fewer awakenings from sleep."

PLMS are involuntary movements of the legs during sleep and are a feature seen in over 80 percent of patients with RLS. Restless Legs Syndrome, a condition that affects up to ten percent of the population, is a neurologic movement disorder characterized by an irresistible urge to move the legs and by uncomfortable or sometimes unpleasant sensations in the legs often described as creeping-crawling, burning or twitching.

These symptoms generally occur at rest, such as when sitting, ly
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