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


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.
Bliwise
D L
DL
Department of Neurology, Emory University Medical School, WMRB, Suite 6000, 1639 Pierce Drive, Atlanta, GA 30322, USA. dbliwis@emory.edu
Freeman
A
A
Ingram
C D
CD
Rye
D B
DB
Chakravorty
S
S
Watts
R L
RL
D000328:Adult; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D017286:Polysomnography; D012148:Restless Legs Syndrome / Q000175:diagnosis / Q000188:drug therapy*; D013997:Time Factors
D018491:Dopamine Agonists; D007211:Indoles; C046649:ropinirole