Background: This multicenter, double-blind, placebo-controlled study assessed the efficacy of rotigotine\ntransdermal patch on apathy and motor symptoms in patients with Parkinsonââ?¬â?¢s disease (PD).\nMethods: Patients with PD-associated apathy (Unified Parkinson's Disease Rating Scale [UPDRS] I item 4\n[motivation] ââ?°Â¥2 and patient-rated Apathy Scale [AS] ââ?°Â¥14) were randomized 1:1:1 to ââ?¬Å?low-doseââ?¬Â rotigotine\n(ââ?°Â¤6 mg/24 h for early PD [those not receiving levodopa] or ââ?°Â¤8 mg/24 h for advanced PD [those receiving\nlevodopa]), ââ?¬Å?high-doseââ?¬Â rotigotine (ââ?°Â¤8 mg/24 h for early PD or ââ?°Â¤16 mg/24 h for advanced PD), or placebo, and\nmaintained at optimal/maximal dose for 12 weeks. Coprimary efficacy variables were: change from baseline to End\nof Maintenance in patient-rated AS and UPDRS II + III total score. Recruitment was stopped after an interim futility\nanalysis; therefore, all p values are exploratory.\nResults: Of 122 patients randomized, 81.1 % completed the study (placebo, n = 32/40 [80.0 %]; low-dose rotigotine,\nn = 30/41 [73.2 %]; high-dose rotigotine, n = 37/41 [90.2 %]). No treatment difference was observed in the change\nin patient-rated AS (least squares mean [95 % confidence interval (CI)] difference: low-dose, 0.04 [âË?â??2.42, 2.50],\np =0.977; high-dose, âË?â??0.22 [âË?â??2.61, 2.18], p = 0.859). Rotigotine improved UPDRS II + III total scores versus placebo\n(least squares mean [95 % CI] treatment difference: low-dose, âË?â??7.29 [âË?â??12.30, âË?â??2.28], p = 0.005; high-dose, âË?â??6.06 [âË?â??10.\n90, âË?â??1.21], p = 0.015), and the ââ?¬Å?mood/apathyââ?¬Â domain of the Non-Motor Symptom Scale as rated by the investigator\n(secondary outcome). The most frequent adverse events in rotigotine-treated patients were application site\nreactions, somnolence, and nausea.\nConclusions: Rotigotine did not improve PD-associated apathy as rated by the patient but provided clinically\nrelevant improvement in motor control and activities of daily living.
Loading....