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Requip for Restless Leg Syndrome
The Food and Drug Administration has approved Requip (ropinirole) to treat moderate to severe Restless Legs Syndrome (RLS). The drug was first approved for Parkinson’s disease in 1997.
Symptoms typically worsen or occur only in the evening or at night, and can disturb sleep.
Ropinirole was found to be effective for RLS in three randomized, double-blind placebo controlled studies in adults diagnosed with moderate to severe RLS.
The studies measured effectiveness of the drug using the International Restless Leg Syndrome Scale, a patient rated scale that measures different aspects of RLS including severity of muscle movement and discomfort, sleep disturbance, mood and overall effect on quality of life.
The Clinical Global Impression-Global Improvement scale was also used. This is an investigator rated scoring of improvement following treatment.
All three studies demonstrated a statistically significant difference between the treatment group receiving Ropinirole and the group receiving placebo.
Reprinted from www.fda.gov
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