scholarly journals Effects of Night-Time Use of Rotigotine on Nocturnal Symptoms in Parkinson’s Disease

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Francesc Vallderiola ◽  
Yaroslau Compta ◽  
Javier Aparicio ◽  
Jaume Tarradellas ◽  
Gabriel Salazar ◽  
...  

Objectives.This open-label study assessed the efficacy and safety of exclusive night-time administration of transdermal rotigotine in patients with nocturnal and early morning PD symptoms.Methods.Patients with PD and nocturnal and early morning symptoms received transdermal rotigotine patches (2–16 mg/24 h) applied in the evening and removed in the morning for 3 months. Sleep disturbance was assessed with modified Parkinson’s Disease Sleep Scale (PDSS-2). Other outcomes included a pain visual analogue scale (VAS) and short-form Parkinson’s Disease Questionnaire (PDQ-8) for quality of life.Results.74 patients completed treatment in this study. At the end of treatment, PDSS-2 total score had improved by mean 10.9 points from baseline (p< 0.001). All three PDSS-2 domain scores (sleep disturbances, nocturnal motor symptoms, and nocturnal symptoms) were also significantly improved by 41%, 56%, and 48%, respectively (p< 0.001). VAS-pain score decreased from 3.2 to 2.3 (p< 0.001). PDQ-8 score decreased from 23.8 to 18.1 (p< 0.001). The most frequently reported adverse events included nausea (9%), anxiety (4%), and dizziness (4%).Conclusions.Night-time administration of transdermal rotigotine is an effective and well tolerated treatment for nocturnal symptoms in patients with PD.

2021 ◽  
Vol 11 (3) ◽  
pp. 316
Author(s):  
Diego Santos García ◽  
Carmen Labandeira Guerra ◽  
Rosa Yáñez Baña ◽  
Maria Icíar Cimas Hernando ◽  
Iria Cabo López ◽  
...  

Some studies observed a benefit of Parkinson’s disease (PD) patients after treatment with safinamide in some non-motor symptoms (NMSs). The aim of this study was to analyze the effectiveness of safinamide on NMS burden in PD. SAFINONMOTOR (an open-label study of the effectiveness of safinamide on non-motor symptoms in Parkinson’s disease patients) is a prospective open-label single-arm study conducted in five centers from Spain. The primary efficacy outcome was the change from baseline (V1) to the end of the observational period (6 months) (V4) in the non-motor symptoms scale (NMSS) total score. Between May/2019 and February/2020 50 patients were included (age 68.5 ± 9.12 years; 58% females; 6.4 ± 5.1 years from diagnosis). At 6 months, 44 patients completed the follow-up (88%). The NMSS total score was reduced by 38.5% (from 97.5 ± 43.7 in V1 to 59.9 ± 35.5 in V4; p < 0.0001). By domains, improvement was observed in sleep/fatigue (−35.8%; p = 0.002), mood/apathy (−57.9%; p < 0.0001), attention/memory (−23.9%; p = 0.026), gastrointestinal symptoms (−33%; p = 0.010), urinary symptoms (−28.3%; p = 0.003), and pain/miscellaneous (−43%; p < 0.0001). Quality of life (QoL) also improved with a 29.4% reduction in the PDQ-39SI (from 30.1 ± 17.6 in V1 to 21.2 ± 13.5 in V4; p < 0.0001). A total of 21 adverse events in 16 patients (32%) were reported, 5 of which were severe (not related to safinamide). Dyskinesias and nausea were the most frequent (6%). Safinamide is well tolerated and improves NMS burden and QoL in PD patients with severe or very severe NMS burden at 6 months.


2020 ◽  
pp. 1-10
Author(s):  
C. Warren Olanow ◽  
Alberto J. Espay ◽  
Fabrizio Stocchi ◽  
Aaron L. Ellenbogen ◽  
Mika Leinonen ◽  
...  

Background: ND0612 is a continuous, subcutaneous levodopa/carbidopa delivery system in development for patients with Parkinson’s disease (PD) experiencing motor fluctuations Objective: Evaluate the efficacy and safety of two ND0612 dosing regimens in patients with PD. Methods: This was a 28-day open-label study (NCT02577523) in PD patients with ≥2.5 hours/day of OFF time despite optimized treatment. Patients were randomized to treatment with either a 24-hour infusion (levodopa/carbidopa dose of 720/90 mg) or a 14-hour ‘waking-day’ infusion (levodopa/carbidopa dose of 538/68 mg plus a morning oral dose of 150/15 mg). In-clinic assessments of OFF time (primary endpoint) and ON time with or without dyskinesia were determined by a blinded rater over 8 hours (normalized to 16 hours). Results: A total of 38 patients were randomized and 33 (87% ) completed the study. Compared to baseline, OFF time for the overall population was reduced by a least squares (LS) mean[95% CI] of 2.0[– 3.3, – 0.7] hours (p = 0.003). ON time with no/mild dyskinesia was increased from baseline by a LS mean of 3.3[2.0, 4.6] hours (p <  0.0001), and ON time with moderate/severe dyskinesia was reduced by a LS mean of 1.2[– 1.8, – 0.5] hours (p≤0.001). Reduction in OFF time was larger in the 24-hour group (– 2.8[– 4.6, – 0.9] hours; p = 0.004) than in the 14-hour group (– 1.3[– 3.1, 0.5] hours; p = 0.16). Complete resolution of OFF time was observed in 42% (n = 8) of patients in the 24-hour group. Infusion site reactions were the most common adverse event. Conclusion: This study demonstrates the feasibility and safety of continuous subcutaneous delivery of levodopa as a treatment for PD and provides preliminary evidence of efficacy.


2020 ◽  
Vol 410 ◽  
pp. 116625 ◽  
Author(s):  
Livia Brusa ◽  
Viviana Ponzo ◽  
Alessandro Stefani ◽  
Roberto Ceravolo ◽  
Giovanni Palermo ◽  
...  

2017 ◽  
Vol 4 (07) ◽  
pp. 1463 ◽  
Author(s):  
Azadeh Memarian ◽  
Afsaneh Sanatkaran ◽  
Seyyed Mohialdin Bahari

Background: The aim of the present study is to evaluate the effects of laughter yoga exercises on anxiety and sleep quality in patients suffering from Parkinson’s disease. Methods: In the study a semi-empirical and applied research design was used, which involved a pre-test and post-test, and appropriate control group. The study consisted of 24 patients suffering from Parkinson’s disease who were referred and admitted to Hazarate Raoul Allah Hospital in Tehran, Iran. The patients ranged in age from 55 to 75 and met the study criteria prior to entering the research study. The patients were randomly divided into two groups – control or experimental (n=12 per group). After completing exercises (laughter yoga), post-evaluation of anxiety and sleep quality of patients in both groups were conducted using questionnaires. For normalization of research data, the Mann-Whitney nonparametric test was used. Statistical analyses were conducted using the SPSS software, with the statistically significant level set at P<0.05. Results: The Mann-Whitney tests indicated that there was a significant difference between the  average stress change as well as sleep quality in patients suffering from Parkinson’s disease (versus control subjects) following laughter yoga exercises. Indeed, regarding sleep quality laughter yoga was only effective on the subjective quality of sleep and latency in sleeping. There was no observation of a significant effect on the duration of sleep, sleep efficiency, sleep disturbances, use of sleeping pills, or daily functions of the patients. Conclusion: The results of the present study demonstrate that laughter yoga exercises can reduce anxiety and improve sleep quality in patients suffering from Parkinson’s disease. As a result, laughter yoga exercises may be beneficial as a complementary therapy with standard treatment methods to reduce anxiety and improve sleep quality in patients with Parkinson's.  


2021 ◽  
Vol 13 ◽  
Author(s):  
Yu Zhang ◽  
Zi en Zhang ◽  
De Shi ◽  
Yi Zhao ◽  
Lihong Huang ◽  
...  

Background: Early morning off (EMO) refers to off-states in the morning in people diagnosed with Parkinson's disease (PwPD). This study determined the clinical manifestations of EMO and the association with nocturnal sleep problems and quality of life (QOL) in Chinese PwPD.Methods: In this multicenter, observational, cross-sectional study, data concerning the clinical manifestations of EMO were collected from PwPD in Shanghai by questionnaire. The stepwise logistic regression was performed to analyze the potential risk factors, as well as whether EMO was an independent risk factor for functional dependency in daily life. The mediation analyses were conducted to evaluate whether nocturnal sleep problems might mediate the association between EMO and the QOL.Results: Among the 454 subjects evaluated, EMO occurred in 39.43% of PwPD across all disease stages. The prevalence of EMO increased as the Hoehn and Yahr stage increased and was observed in 35.60% of patients in stages 1–2.5 and 48.85% of patients in stages 3–5. EMO was associated with non-motor symptoms (NMSs). The predominant NMSs associated with EMO were nocturnal sleep problems (98.90%), mood/cognition impairment (93.90%), decreased attention/memory (91.60%), gastrointestinal symptoms (91.60%), and urinary urgency (90.50%). The QOL of PwPD with EMO was significantly reduced (P &lt; 0.001). Moreover, nocturnal sleep problems might partially mediate this relationship (indirect effect: β = 13.458, 95% boot CI: 6.436, 22.042).Conclusion: PwPD have EMO throughout all stages of the disease. Patients with EMO have severe motor symptoms and NMSs. EMO decreases the QOL in PwPD and this relationship is partially mediated by nocturnal sleep problems. In light of these findings, it is suggested that recognition and appropriate treatment of EMO and nocturnal sleep problems could improve the management of PwPD.


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