Restless legs syndrome (RLS), characterized by sensory and motor abnormalities of the limbs associated with an urge to move, affects five to 10 percent of the population. RLS can lead to severe sleep disruption and daytime fatigue, compromising one's ability to function normally. People with RLS may be compelled to get out of bed several times during the night to walk or otherwise move their legs to relieve pain or discomfort. Though RLS was initially described in 1945, most affected individuals remain undiagnosed and untreated.
"Previous studies have indicated the efficacy of pergolide in treating RLS," notes study author Claudia Trenkwalder, MD, Department of Clinical Neurophysiology at Georg August University, Goettingen, Germany. "However, they generally included small numbers of patients orwshort durations of treatment, limiting conclusions regarding the clinical use of pergolide therapy." Trenkwalder and other researchers collaborated on this prospective, placebo-controlled longitudinal study designed to determine the efficacy as well as the long-term effects of pergolide in treating RLS.
One hundred RLS patients ages 18 to 75 were enrolled in the study through 17 medical centers in seven countries (Australia, Belgium, Finland, Germany, Italy, Netherlands, Spain). This prospective study, conducted from September 1998 through July 2000, consisted of two phases: a double-blind, parallel, randomized six-week comparison of pergolide versus placebo; and a long-term extension in which responders to either pergolide or placebo in phase one continued to receive blinded medication, and non-responders received open
Contact: Kathy Stone
American Academy of Neurology