Abstract | OBJECTIVE: 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.
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Authors | Wolfgang 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 |
Journal | Sleep medicine
(Sleep Med)
Vol. 11
Issue 9
Pg. 848-56
(Oct 2010)
ISSN: 1878-5506 [Electronic] Netherlands |
PMID | 20813583
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Tetrahydronaphthalenes
- Thiophenes
- rotigotine
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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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