Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: a randomized, placebo-controlled polysomnographic study.
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.
Oertel
Wolfgang H
WH
Department of Neurology, Philipps Universität, Rudolf-Bultmann-Str. 8, Marburg, Germany.
Benes
Heike
H
Garcia-Borreguero
Diego
D
Högl
Birgit
B
Poewe
Werner
W
Montagna
Pasquale
P
Ferini-Strambi
Luigi
L
Sixel-Döring
Friederike
F
Trenkwalder
Claudia
C
Partinen
Markku
M
Saletu
Bernd
B
Polo
Olli
O
Fichtner
Andreas
A
Schollmayer
Erwin
E
Kohnen
Ralf
R
Cassel
Werner
W
Penzel
Thomas
T
Stiasny-Kolster
Karin
K
D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009068:Movement / Q000187:drug effects; D017286:Polysomnography; D012148:Restless Legs Syndrome / Q000188:drug therapy*; D012720:Severity of Illness Index; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D057968:Transdermal Patch; D016896:Treatment Outcome; D055815:Young Adult
D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine