Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome

Prog Neuropsychopharmacol Biol Psychiatry. 2013 Jan 10;40:326-33. doi: 10.1016/j.pnpbp.2012.10.012. Epub 2012 Oct 25.


The present study aimed to examine the long-term efficacy and safety of rotigotine treatment for restless legs syndrome (RLS), as well as the rate of clinically significant augmentation, in a 1-year open-label study of Japanese subjects. Japanese patients with RLS who had been treated with rotigotine or placebo in a double-blind trial were enrolled in a 1-year, open-label, uncontrolled extension study and treated with rotigotine at a dose of up to 3 mg/24 h after an 8-week titration phase. Outcomes included International Restless Legs Syndrome Study Group rating scale (IRLS scale), Pittsburgh Sleep Quality Index (PSQI), safety, and investigator-/expert panel-assessed augmentation (including Augmentation Severity Rating Scale). Overall, 185 patients entered the open-label study and 133 completed the study. IRLS and PSQI total scores improved throughout the 52-week treatment period (IRLS, from 23.2±5.1 to 7.8±7.6 and PSQI, from 8.0±3.1 to 5.0±2.9). Treatment-emergent adverse events were mild to moderate in severity, and included application site reactions (52.4%) and nausea (28.6%). Clinically significant augmentation occurred in five patients (2.7%). These results indicate a good long-term efficacy of rotigotine for treating RLS, with a relatively low risk of clinically significant augmentation.

Trial registration: ClinicalTrials.gov NCT01562743.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Asian Continental Ancestry Group
  • Dopamine Agonists / adverse effects
  • Dopamine Agonists / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Restless Legs Syndrome / drug therapy*
  • Severity of Illness Index
  • Tetrahydronaphthalenes / adverse effects
  • Tetrahydronaphthalenes / therapeutic use*
  • Thiophenes / adverse effects
  • Thiophenes / therapeutic use*
  • Treatment Outcome


  • Dopamine Agonists
  • Tetrahydronaphthalenes
  • Thiophenes
  • rotigotine

Associated data

  • ClinicalTrials.gov/NCT01562743