• Sleep medicine · Dec 2008

    Randomized Controlled Trial

    Effect of pramipexole on RLS symptoms and sleep: a randomized, double-blind, placebo-controlled trial.

    • Luigi Ferini-Strambi, Dagfinn Aarskog, Markku Partinen, K Ray Chaudhuri, Mandy Sohr, Daniela Verri, and Stefan Albrecht.
    • Institute San Raffaele Turro, Milan, Italy.
    • Sleep Med. 2008 Dec 1;9(8):874-81.

    BackgroundPatients with Restless Legs Syndrome (RLS) often seek treatment because of sleep problems related to nocturnal symptoms. Our goal was to test the ability of pramipexole to improve sleep in RLS patients and to reconfirm its efficacy for primary RLS symptoms.MethodsAdults with moderate or severe RLS were randomized to receive placebo or pramipexole (flexibly titrated from 0.25 to 0.75mg), 2-3h before bedtime for 12 weeks. The co-primary outcome measures were change in Medical Outcomes Study (MOS) sleep disturbance score and International RLS Study Group Rating Scale (IRLS) score at 12 weeks.ResultsThe intent-to-treat population included 357 patients: 178 received pramipexole and 179 received placebo. At 12 weeks, the adjusted mean change from baseline was greater for pramipexole (vs. placebo) for IRLS score (-13.4+/-0.7 vs. -9.6+/-0.7) and MOS sleep disturbance score (-25.3+/-1.5 vs. -16.8+/-1.5) (pConclusionsPramipexole is effective and well-tolerated for RLS and related sleep disturbance.

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