Ropinirole in the Treatment of Patients With Restless Legs Syndrome: A US-Based Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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Restless legs syndrome (RLS), a condition found in 5% to 10% of adults, consists of an urge to move the legs usually accompanied by uncomfortable sensations that tend to occur at times of rest or inactivity, especially at night. Movement relieves the symptoms, at least in part. The timing of symptoms and periodic leg movements (PLMs) make it difficult to fall and remain asleep, and affected patients experience a lowered quality of life. Because dopaminergic dysfunction appears to have a central role in RLS, dopamine agonists are the preferred treatment in most patients having symptoms on a daily basis.

This study compared the dopamine agonist ropinirole with placebo in a 12-week double-blind, randomized, flexible-dose trial that enrolled patients who had moderate to severe primary RLS based on International Restless Legs Scale (IRLS) scores. The trial was completed by 164 patients randomized to receive ropinirole and 167 given placebo. Daily doses of 0.25 to 4 mg were given as needed and as tolerated 1 to 3 hours before bedtime.

After 12 weeks, patients taking ropinirole had a significantly greater reduction in IRLS scores than did placebo recipients. The mean daily dose of ropinirole at this time was 2.1 mg. Significantly more of the actively treated patients exhibited a response on the Clinical Global Impression-I scale, and PLM scores also favored ropinirole. Treated patients improved in all domains of the Medical Outcomes Study sleep scale, and they had a substantially greater change from baseline in an RLS Quality of Life questionnaire than did placebo patients. Anxiety scores decreased with ropinirole treatment, whereas depression scores declined in both groups. A majority of patients in both groups reported adverse effects, but most of these were mild or moderate. Only one patient—in the placebo group—had a serious adverse effect consisting of chest pain.

These findings support those from previous international studies of ropinirole as a treatment for RLS. The drug consistently lessens symptoms of RLS, reduces anxiety, improves sleep and the overall self-rated quality of life, and is generally well tolerated.

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