Randomized, double-blind, placebo-controlled, short-term trial of ropinirole in restless legs syndrome

Sleep Med. 2005 Mar;6(2):141-7. doi: 10.1016/j.sleep.2004.12.002.


Background and purpose: Restless legs syndrome (RLS) is a condition characterized by an urge to move the legs, usually accompanied by lower limb paresthesias. These symptoms worsen at rest, are relieved by activity, and are worse at night. Previous studies have suggested that dopaminergic drugs such as L-dopa and dopamine agonists, as well as benzodiazepines and opioids, can treat RLS successfully. The purpose of this study was to test the clinical efficacy of ropinirole, a D2/D3 agonist, in the treatment of RLS in a double-blind, short-term, placebo-controlled clinical trial.

Patients and methods: After undergoing successful open-label titration and dose adjustments with ropinirole for RLS symptoms over a period of 4 weeks, 22 RLS patients (mean age=50.8; mean duration of symptoms=26.1 years) were randomized to receive either placebo (n=13) or ropinirole (n=9) for 2 additional weeks. Outcome measures included assessment of periodic leg movements in sleep (PLMS) recorded with nocturnal polysomnography and RLS symptoms as assessed with the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale. Secondary outcomes included sleep macroarchitecture.

Results: Results indicated that relative to placebo, ropinirole, at a mean dose of 1.4mg HS significantly decreased PLMS and RLS symptoms. Sleep macroarchitecture did not change. Side effects were typical of all dopamine agonists and were dose related. The majority of patients elected to continue treatment with ropinirole upon study completion.

Conclusions: Ropinirole successfully treated long-standing RLS and can be considered a viable short-term treatment for this condition.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Dopamine Agonists / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Indoles / therapeutic use*
  • International Cooperation
  • Male
  • Middle Aged
  • Polysomnography
  • Restless Legs Syndrome / diagnosis
  • Restless Legs Syndrome / drug therapy*
  • Time Factors


  • Dopamine Agonists
  • Indoles
  • ropinirole