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Rotigotine improves restless legs syndrome: A 6‐month randomized, double‐blind, placebo‐controlled trial in the United States
Author(s) -
Hening Wayne A.,
Allen Richard P.,
Ondo William G.,
Walters Arthur S.,
Winkelman John W.,
Becker Philip,
Bogan Richard,
Fry June M.,
Kudrow David B.,
Lesh Kurt W.,
Fichtner Andreas,
Schollmayer Erwin
Publication year - 2010
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.23157
Subject(s) - rotigotine , restless legs syndrome , placebo , medicine , nausea , anesthesia , randomized controlled trial , transdermal , parkinson's disease , pharmacology , neurology , psychiatry , alternative medicine , disease , pathology
Abstract This randomized, double‐blinded, placebo‐controlled trial (NCT00135993) assessed efficacy and safety of the dopamine agonist rotigotine in the treatment of idiopathic restless legs syndrome (RLS) over a 6‐month maintenance period. A total of 505 eligible participants with moderate to severe RLS (IRLS sum score ≥ 15) were randomly assigned to five groups to receive either placebo or rotigotine (0.5, 1, 2, or 3 mg/24 hr) delivered by once‐daily transdermal patch (fixed‐dose regimen). The two co‐primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions (CGI‐1) score. On both primary measures, 2 and 3 mg/24 hr rotigotine was superior to placebo ( P < 0.001). Adjusted treatment differences to placebo for the IRLS sum score were −4.5 (95% CI: −6.9, −2.2) for 2 mg/24 hr rotigotine, −5.2 (95% CI: −7.5, −2.9) for 3 mg/24 hr rotigotine, and for CGI item 1 −0.65 (95% CI: −1.0, −0.3) and −0.9 (95% CI: −1.3, −0.5) for the 2 and 3 mg/24 hr doses, respectively. Skin reactions (27%) and known dopaminergic side effects such as nausea (18.1%) and headache (11.6%) were mostly mild or moderate in rotigotine subjects. Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms. Treatment efficacy was maintained throughout the 6‐month double‐blind period. © 2010 Movement Disorder Society