BACKGROUND: Non-motor symptoms of Parkinson's disease (PD) represent major causes of morbidity. RECOVER, a randomized controlled trial of rotigotine transdermal system, was the first prospective controlled trial to use the Non-Motor Symptoms Scale (NMSS) as an exploratory outcome for assessment of treatment effects on non-motor symptoms in PD. Rotigotine improved NMSS total score compared with placebo, and the "Sleep/fatigue" and "Mood/apathy" domains. This post hoc analysis further characterizes the effects of rotigotine on sleep/fatigue and mood/apathy. METHODS:Patients with PD and unsatisfactory early-morning motor impairment were randomized to transdermal patches of rotigotine (2-16 mg/24 h) or placebo. Treatment was titrated to optimal dose over 1-8 weeks, maintained for 4 weeks. The NMSS was assessed at baseline and end of treatment. Post hoc analyses are presented for individual items of the "Sleep/fatigue" and "Mood/apathy" domains. The interpretation of p-values is considered exploratory in nature. RESULTS: Of 287 patients randomized, NMSS data were available for 267 patients (178rotigotine, 89 placebo). Within the "Sleep/fatigue" domain there was a significant difference, in favor of rotigotine, in change from baseline score in 1 of 5 items: "fatigue (tiredness) or lack of energy" (ANCOVA, p < 0.0001). Within the "Mood/apathy" domain, there were significant differences in favor of rotigotine in 4 of 7 items: "lost interest in surroundings" (p < 0.0001), "lost interest in doing things" (p < 0.0001), "seems sad or depressed" (p < 0.01), and "difficulty experiencing pleasure" (p < 0.05). CONCLUSIONS:Rotigotine transdermal system may improve non-motor symptoms such as fatigue, symptoms of depression, anhedonia, and apathy in patients with PD; further prospective controlled studies are required to confirm this post hoc analysis.
RCT Entities:
BACKGROUND: Non-motor symptoms of Parkinson's disease (PD) represent major causes of morbidity. RECOVER, a randomized controlled trial of rotigotine transdermal system, was the first prospective controlled trial to use the Non-Motor Symptoms Scale (NMSS) as an exploratory outcome for assessment of treatment effects on non-motor symptoms in PD. Rotigotine improved NMSS total score compared with placebo, and the "Sleep/fatigue" and "Mood/apathy" domains. This post hoc analysis further characterizes the effects of rotigotine on sleep/fatigue and mood/apathy. METHODS:Patients with PD and unsatisfactory early-morning motor impairment were randomized to transdermal patches of rotigotine (2-16 mg/24 h) or placebo. Treatment was titrated to optimal dose over 1-8 weeks, maintained for 4 weeks. The NMSS was assessed at baseline and end of treatment. Post hoc analyses are presented for individual items of the "Sleep/fatigue" and "Mood/apathy" domains. The interpretation of p-values is considered exploratory in nature. RESULTS: Of 287 patients randomized, NMSS data were available for 267 patients (178 rotigotine, 89 placebo). Within the "Sleep/fatigue" domain there was a significant difference, in favor of rotigotine, in change from baseline score in 1 of 5 items: "fatigue (tiredness) or lack of energy" (ANCOVA, p < 0.0001). Within the "Mood/apathy" domain, there were significant differences in favor of rotigotine in 4 of 7 items: "lost interest in surroundings" (p < 0.0001), "lost interest in doing things" (p < 0.0001), "seems sad or depressed" (p < 0.01), and "difficulty experiencing pleasure" (p < 0.05). CONCLUSIONS:Rotigotine transdermal system may improve non-motor symptoms such as fatigue, symptoms of depression, anhedonia, and apathy in patients with PD; further prospective controlled studies are required to confirm this post hoc analysis.