A Randomized Controlled Exploratory Pilot Study to Evaluate the Effect of XXXX Transdermal Patch on @entity191 -Associated @entity1118 .

@entity1 @entity3034 @entity26742 @entity935 @entity191 @entity158 @entity1118
UNASSIGNED: @entity158 is a troublesome nonmotor symptom of @entity191 ( @entity191 ). This double-blind exploratory pilot study (NCT01744496) was the first to specifically investigate the effect of a @entity935 agonist on @entity191 -associated @entity158 as primary outcome. @entity1 with @entity191 (ie, receiving @entity3034 ) and at least moderate @entity191 -associated @entity1118 (>= 3 months, >= 4 points on 11-point @entity158 scale) were randomized to @entity26742 (optimal/maximum dose  <=16 mg/24h) or placebo, and maintained for 12 weeks. Primary efficacy variable: change in @entity158 severity ( @entity158 scale) from baseline to end of maintenance. Secondary variables included percentage of responders (>= 2-point @entity158 scale reduction), King's @entity191 @entity158 Scale (KPPS) domains, and @entity191 Questionnaire (PDQ-8). Statistical analyses were exploratory. Of 68 randomized @entity1 , 60 ( @entity26742 , 30; placebo, 30) were evaluable for efficacy. A numerical improvement in @entity158 was observed in favor of @entity26742 ( @entity158 scale: least-squares mean [95%CI] treatment difference, -0.76 [-1.87 to 0.34]; P = .172), and proportion of responders was 18/30 (60%) @entity26742 versus 14/30 (47%) placebo. An    2-fold numerical improvement in KPPS domain "fluctuation-related @entity158 " was observed with @entity26742 versus placebo. @entity26742 improved PDQ-8 versus placebo (-8.01 [-15.56 to -0.46]; P = .038). These results suggest @entity26742 may improve @entity191 -associated @entity158 ; a large-scale confirmatory study is needed. This article is protected by copyright. All rights reserved.
