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Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: a randomized, placebo-controlled polysomnographic study.

AbstractOBJECTIVE:
To assess the efficacy of rotigotine transdermal patch in subjects with moderate to severe idiopathic restless legs syndrome (RLS) and periodic limb movement (PLM) in sleep in a double-blind, randomized, placebo-controlled, multicenter study (NCT00275236).
METHODS:
Sixty-seven (46 rotigotine, 21 placebo) subjects applied rotigotine (maximum 3mg/24h) or placebo patches once-daily during a 4-week maintenance period; efficacy evaluations used polysomnographic measures and clinician/patient ratings.
RESULTS:
Mean PLM index (PLMI; PLM/h time in bed) decreased more with rotigotine (50.9/h to 8.1/h) than with placebo (37.4/h to 27.1/h; adjusted treatment ratio 4.25 (95% CI [2.48,7.28], p<0.0001). PLM during sleep with arousal index (PLMSAI; 8.57/h to 2.47/h under rotigotine, 6.5/h to 4.95/h under placebo; adjusted treatment difference: -3.12 (95% CI [-5.36, -0.88], p=0.0072) also improved more under rotigotine. At end of maintenance, 39% of rotigotine subjects had PLMI levels <5/h and 26% showed no RLS symptoms (IRLS=0), whereas no placebo subject met these criteria. Common drug-related adverse events for rotigotine and placebo included nausea (21.7%/4.8%), headache (17.4%/14.3%), application site reactions (17.4%/4.8%), and somnolence (10.9%/9.5%); most were mild to moderate in intensity.
CONCLUSIONS:
Rotigotine transdermal patch was efficacious and well tolerated in the short-term treatment of RLS motor symptoms and associated sleep disturbances.
AuthorsWolfgang H Oertel, Heike Benes, Diego Garcia-Borreguero, Birgit Högl, Werner Poewe, Pasquale Montagna, Luigi Ferini-Strambi, Friederike Sixel-Döring, Claudia Trenkwalder, Markku Partinen, Bernd Saletu, Olli Polo, Andreas Fichtner, Erwin Schollmayer, Ralf Kohnen, Werner Cassel, Thomas Penzel, Karin Stiasny-Kolster
JournalSleep medicine (Sleep Med) Vol. 11 Issue 9 Pg. 848-56 (Oct 2010) ISSN: 1878-5506 [Electronic] Netherlands
PMID20813583 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Tetrahydronaphthalenes
  • Thiophenes
  • rotigotine
Topics
  • Adolescent
  • Adult
  • Aged
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Movement (drug effects)
  • Polysomnography
  • Restless Legs Syndrome (drug therapy)
  • Severity of Illness Index
  • Tetrahydronaphthalenes (administration & dosage, adverse effects, therapeutic use)
  • Thiophenes (administration & dosage, adverse effects, therapeutic use)
  • Transdermal Patch
  • Treatment Outcome
  • Young Adult

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