Rotigotine for nocturnal hypokinesia in Parkinson's disease: Quantitative analysis of efficacy from a randomized, placebo-controlled trial using an axial inertial sensor
Parkinsonism & Related Disorders Aug 14, 2017
Bhidayasiri R, et al. – Using a wearable sensor, the physicians assessed the efficacy of rotigotine transdermal patch in the management of nocturnal immobility. They revealed that in nocturnal symptoms, the rotigotine patch provided a significant improvement as evaluated using both objective measures and clinical rating scales. The study indicated the feasibility of using wearable sensors to record objective outcomes in Parkinson's disease (PD)–related clinical trials.
Methods- The physicians randomized 34 PD subjects with nocturnal immobility to receive rotigotine transdermal patch (mean ± SD of 10.46 ± 4.63 mg/24 h, n = 17) or placebo patch (n = 17).
- They titrated treatment to an optimal dose over 1-8 weeks, then maintained for 4 weeks.
- Objective parameters assessing axial rotation measured using an axial inertial sensor (the NIGHT-Recorder) over two nights at the patients' home were the primary endpoints.
- They also performed scale-based assessments.
- In favor of rotigotine, there was a significant difference in change from baseline score in the number of turns in bed (ANCOVA, p = 0.001), and degree of axial turn (p = 0.042).
- These objective improvements were reflected by significantly greater improvements in clinical scale-based assessments, including the Unified Parkinson's Disease Rating Scale (UPDRS) total scores (p = 0.009), UPDRS-motor scores (p < 0.001), UPDRS-axial scores (p = 0.01), the Modified Parkinson's Disease Sleep Scale (p < 0.001), the Nocturnal Akinesia Dystonia and Cramp Scale (p = 0.003) and the eight-item PD Questionnaire (PDQ-8) scores (p = 0.01) from baseline to end of treatment in patients given rotigotine than placebo.
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