Successful treatment of the idiopathic restless legs syndrome in a randomized double-blind trial of oxycodone versus placebo.
In a double-blind randomized crossover trial, oxycodone or placebo was given in divided night-time doses to 11 patients with idiopathic restless legs syndrome (RLS) for 2 weeks prior to appropriate polysomnographic studies. Under double-blinded conditions, patients were asked to do daily ratings of their leg sensations, motor restlessness and daytime alertness on a 1-4 scale for the 2 weeks prior to the polysomnographic studies and for the nights of the polysomnographic studies as well. Leg sensations (p < 0.009), motor restlessness (p < 0.006) and daytime alertness (p < 0.03) were significantly improved on oxycodone as compared to baseline or placebo. Patients were studied polysomnographically under double-blinded conditions for 2 nights in each phase of the protocol. On an average dose of 15.9 mg oxycodone (equivalent to approximately three 5-mg tablets of commercial preparation), there was a statistically significant reduction in the number of periodic limb movements in sleep [(PLMS)/hour sleep (p < 0.004)] and in the number of arousals/hour sleep (p < 0.009) on drugs as compared to baseline or placebo. A statistically significant improvement was also noted in sleep efficiency (p < 0.006) and 10 of the 11 patients preferred oxycodone over placebo. We conclude that oxycodone is an effective treatment for RLS and PLMS.
Walters
A S
AS
Department of Neurology, UMDNJ Robert Wood Johnson University Hospital, New Brunswick 08903-0019.
Wagner
M L
ML
Hening
W A
WA
Grasing
K
K
Mills
R
R
Chokroverty
S
S
Kavey
N
N
D000328:Adult; D000368:Aged; D002940:Circadian Rhythm / Q000187:drug effects; D003430:Cross-Sectional Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010098:Oxycodone / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos; D017286:Polysomnography; D012148:Restless Legs Syndrome / Q000188:drug therapy*; D012895:Sleep, REM / Q000187:drug effects; D013577:Syndrome; D014851:Wakefulness / Q000187:drug effects
D010919:Placebos; D010098:Oxycodone