• Diego Garcia-Borreguero, Jeffrey Patrick, Sarah DuBrava, Philip M Becker, Alan Lankford, Crystal Chen, Jeffrey Miceli, Lloyd Knapp, and Richard P Allen.
• Sleep Research Institute, Madrid, Spain.
• Sleep. 2014 Jan 1;37(4):635-43.

Study ObjectivesTo compare pregabalin versus placebo and pramipexole for reducing restless legs syndrome (RLS)-related sleep disturbance.DesignRandomized, double-blinded, crossover trial.SettingTwenty-three US sleep centers.ParticipantsEighty-five individuals with moderate to severe idiopathic RLS and associated sleep disturbance.InterventionsParticipants were randomized across 6 treatment sequences comprising three 4-week periods on pregabalin 300 mg/day (n = 75), pramipexole 0.5 mg/day (n = 76), or placebo (n = 73).Measurements And ResultsPolysomnography was conducted over 2 nights at the end of each period. Primary (wake after sleep onset [WASO], pregabalin vs placebo) and key secondary endpoints were analyzed for statistical significance, with descriptive statistics for other endpoints. Pregabalin improved sleep maintenance, demonstrated by reductions in WASO (-27.1 min vs placebo [P < 0.0001]; -26.9 vs pramipexole) and number of awakenings after sleep onset (-2.7 vs placebo; -7.9 vs pramipexole [P < 0.0001]) by polysomnography, and an increase in subjective total sleep time (30.8 min vs placebo [P < 0.0001]; 26.8 vs pramipexole). Pregabalin also increased slow wave sleep duration (20.9 min vs placebo; 32.1 vs pramipexole [P < 0.0001]). Reduction in periodic limb movement arousal index (PLMAI) with pregabalin was similar to pramipexole and greater than placebo (-3.7 PLMA/h [P < 0.0001]), although reduction in total PLM in sleep was less than for pramipexole.ConclusionsThis study demonstrated improvements in objective and subjective measures of sleep maintenance and sleep architecture with pregabalin compared with placebo and pramipexole. Effects of pregabalin on periodic limb movement arousal index were comparable to pramipexole.Trial RegistrationClinicalTrials.gov identifier, NCT00991276; http://clinicaltrials.gov/show/NCT00991276.

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