Drug Reduces Restless Legs Syndrome
Requip Doesn't Cure Condition but Helps Symptoms, Says Study
Dec. 15, 2004 -- A medication used to treat Parkinson's disease is showing
promise in treating people with restless legs syndrome, according to a new
Restless legs syndrome can be extremely disruptive, especially when it comes
to sleep. Patients have an irresistible urge to move their legs and may feel
crawling, tingling, pulling, or painful sensations in their legs. Though the
cause of restless legs syndrome is unknown, studies have suggested that the
condition results from abnormalities in the brain chemical known as
A study in the journal Movement Disorders shows the Parkinson's
drug Requip, which works like dopamine, relieves symptoms of restless legs
syndrome, improving sleep and quality of life for people with the
Still, it doesn't cure the problem, which affects one in 10 people to
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The FDA is reviewing Requip as a treatment for restless legs syndrome. Made
by WebMD sponsor GlaxoSmithKline, the drug directly stimulates nerve cells in
the brain that aren't being stimulated by dopamine. A similar drug called
Mirapex has also shown promise in small clinical trials.
Requip and Mirapex are prescribed to help control the tremors and shaking
seen with Parkinson's disease. Other drugs that affect dopamine have also been
tried for restless legs syndrome, but some may cause scarring of heart
Requip was tested against a placebo pill in more than 260 restless legs
patients in North America, Europe, and Australia. Researchers included Arthur
Walters, MD, of the New Jersey Neuroscience Institute at JFK Medical
Participants were split into two groups. One group took Requip one to three
hours before bedtime every day for 12 weeks, starting at 0.25 mg per day and
increasing as necessary to a maximum dose of 4 mg daily.
The other participants took a placebo. No one knew whether they were taking
the drug or the placebo.
There is no lab test for restless legs syndrome, so participants' reports
were important. They rated any changes in their symptoms, as well as their
sleep and quality of life.
By the study's end, 60% of the Requip group said their symptoms were
"much" or "very much" improved, compared with 40% of the
placebo group. Some improvements were seen within a week and lasted throughout
Patients taking Requip also said they slept better at night and felt less
drowsy during the day. Compared with the placebo group, they reported feeling
more energetic, sociable, and less tired.
The drug was well tolerated, say the researchers. Most side effects were
mild or moderate and included nausea, headache, fatigue, dizziness, upper
respiratory tract infection, and vomiting. Less than 10% of participants in
each group quit the study because of side effects.
The study was conducted in 2002. Requip also showed promise in a similar
restless legs study conducted in Europe and reported in January 2004.