Abstract
In a multinational, double-blind, placebo-controlled trial (NCT00474058), 287 subjects with Parkinson's disease (PD) and unsatisfactory early-morning motor symptom control were randomized 2:1 to receive rotigotine (2–16 mg/24 hr [n = 190]) or placebo (n = 97). Treatment was titrated to optimal dose over 1–8 weeks with subsequent dose maintenance for 4 weeks. Early-morning motor function and nocturnal sleep disturbance were assessed as coprimary efficacy endpoints using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Examination) measured in the early morning prior to any medication intake and the modified Parkinson's Disease Sleep Scale (PDSS-2) (mean change from baseline to end of maintenance [EOM], last observation carried forward). At EOM, mean UPDRS Part III score had decreased by −7.0 points with rotigotine (from a baseline of 29.6 [standard deviation (SD) 12.3] and by −3.9 points with placebo (baseline 32.0 [13.3]). Mean PDSS-2 total score had decreased by −5.9 points with rotigotine (from a baseline of 19.3 [SD 9.3]) and by −1.9 points with placebo (baseline 20.5 [10.4]). This represented a significantly greater improvement with rotigotine compared with placebo on both the UPDRS Part III (treatment difference: −3.55 [95% confidence interval (CI) −5.37, −1.73]; P = 0.0002) and PDSS-2 (treatment difference: −4.26 [95% CI −6.08, −2.45]; P < 0.0001). The most frequently reported adverse events were nausea (placebo, 9%; rotigotine, 21%), application site reactions (placebo, 4%; rotigotine, 15%), and dizziness (placebo, 6%; rotigotine 10%). Twenty-four-hour transdermal delivery of rotigotine to PD patients with early-morning motor dysfunction resulted in significant benefits in control of both motor function and nocturnal sleep disturbances. © 2010 Movement Disorder Society
Highlights
Parkinson’s disease (PD) is characterized by motor symptoms including nocturnal and early morning dystonia and akinesia and is associated with nonmotor symptoms, such as sleep disorders.[1]
24-hour transdermal rotigotine treatment was associated with significant benefits versus placebo in the management of early morning motor impairment and nocturnal sleep disturbances
Rotigotine was associated with improvements in night-time disabilities, and possibly dopaminergic nonmotor daytime symptoms as well
Summary
Parkinson’s disease (PD) is characterized by motor symptoms including nocturnal and early morning dystonia and akinesia and is associated with nonmotor symptoms, such as sleep disorders.[1]. Effective management of nocturnal and early morning PD symptoms may be achieved with either a long-acting treatment or by continuous administration of a short-acting treatment.[2,3,6] Rotigotine is a non-ergoline dopamine agonist that is applied once daily using a transdermal patch, providing 24 hours of continuous drug delivery, and is generally well tolerated.[7] Significant treatment benefits of rotigotine have been observed in both early and advanced PD and include improvements in activities of daily living and motor symptoms, clinically relevant reductions in ‘‘off’’ time, and reductions in concomitant L-dopa dose.[8] Rotigotine’s potential to improve early morning motor function and sleep-associated problems in PD was demonstrated recently by two large controlled studies[9] that showed a reduction in the proportion of patients awakening in an ‘‘off’’ state
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