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| |  SLEEP MEETING: Leading Parkinson’s Disease Drug, Mirapex, Calms Restless Legs ORLANDO, FL. -- June 25, 1999 -- Restless legs syndrome, a movement disorder that affects more than 10 million Americans, can be safely and effectively treated with pramipexole, a medication used to treat Parkinson’s disease, according to results presented during the 13th annual meeting of the Associated Professional Sleep Societies (APSS). Dr. Jacques Montplaisir, lead study author and director of the Center for Sleep Studies, Hopital du Sacre-Coeur de Montreal, reported that “pramipexole is probably the most potent therapeutic agent ever tested for restless legs syndrome.” Characterized by unpleasant leg sensations that occur usually while the affected individual is at rest, restless legs syndrome is described by patients as feeling like “pins and needles”, “internal itch” or a “creeping or crawling” sensation. Symptoms worsen in severity from daytime to nighttime, at times making it difficult to sleep or causing the patient to wake up in the middle of the night. Complaints of chronic bedtime leg restlessness are highly prevalent, affecting approximately 10 percent of the general population. “Restless legs syndrome is a real disease that can impact quality of life for these patients,” said Dr. Montplaisir. “The sufferers often try to relieve the symptoms by vigorously moving their legs or walking around during the night, both of which can seriously interrupt their sleep and thereby impact their performance the next day.” The study of ten patients, showed that pramipexole had major therapeutic effects on sensory and motor manifestations of restless legs syndrome and alleviated restlessness at bedtime and during the night. In addition, pramipexole dramatically reduced the PLMS index (number of periodic limb movements per hour of sleep) down to normal values. A follow-up study of seven of these patients showed persistent therapeutic effect with pramipexole after a mean of 5.4 months at a mean dosage of 0.5 mg, as measured with home questionnaires.
Study Design Ten patients with restless legs syndrome were evaluated before and after two one-month treatments (placebo and pramipexole) at an increasing dosage of up to 1.5 mg, administered in a double-blind cross-over fashion. For each of the four conditions (baseline, placebo, withdrawal and pramipexole), the severity of symptoms was assessed by one week of home questionnaires, a one-hour immobilization test and two consecutive nights of sleep laboratory recordings. Results were analyzed to rule out a carryover effect. Part of these results was recently published in Neurology. The most frequently reported side effects in the study of ten people were nausea, dizziness and fatigue but none of these side effects led to discontinuation of treatment. Pramipexole is a second-generation dopamine agonist currently indicated for the treatment of early and late stage idiopathic Parkinson’s disease. The U.S. Food and Drug Administration (FDA) approved the medication (Mirapex® pramipexole dihydrochloride tablets) for use in Parkinson’s disease in 1997. Traditional drug therapies for restless legs syndrome include older dopaminergic agents such as levodopa, bromocriptine and pergolide, and benzodiazepines, opioids and anticonvulsants. These medications have varying degrees of effectiveness in relieving symptoms of restless legs syndrome. “These findings with pramipexole are really exciting in that they indicate that there may be a large role for pramipexole in the future treatment of restless legs syndrome,” said Catherine Friedrich Murray, executive director, Restless Legs Syndrome Foundation. “Because of its name, restless legs syndrome may sound trivial, but it is a real and treatable disorder,” she added. “Restless legs syndrome can have a devastating impact on quality of life for afflicted individuals -- affecting their ability to work, travel and engage in social activities while also affecting their family members.”
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