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 rest less legs syndrome (RLS) for 2 weeks prior to appropriate polysomnogra phic studies. Under double-blinded conditions, patients were asked to do daily ratings of their leg sensations, motor restlessness and dayti me alertness on a 1-4 scale for the 2 weeks prior to the polysomnograp hic studies and for the nights of the polysomnographic studies as well . Leg sensations (p < 0.009), motor restlessness (p < 0.006) and dayti me alertness (p < 0.03) were significantly improved on oxycodone as co mpared to baseline or placebo. Patients were studied polysomnographica lly under double-blinded conditions for 2 nights in each phase of the protocol. On an average dose of 15.9 mg oxycodone (equivalent to appro ximately three 5-mg tablets of commercial preparation), there was a st atistically significant reduction in the number of periodic limb movem ents in sleep [(PLMS)/hour sleep (p < 0.004)] and in the number of aro usals/hour sleep (p < 0.009) on drug as compared to baseline or placeb o. A statistically significant improvement was also noted in sleep eff iciency (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.