Open-Label Study of Sleep Disturbances in Patients with Parkinson’s Disease Treated with Rasagiline

AbstractBackground: The prevalence of sleep disturbances among patients with Parkinson’s disease (PD) is estimated to occur in 37% to 98% of patients. Sleep disturbances have been associated with a reduced quality of life for patients with PD. The objective of this study was to assess the impact of rasagiline treatment on the severity of sleep disturbances among patients with idiopathic PD. Methods: In this open-label, multicentre study, 110 adult patients with idiopathic PD were treated with rasagiline either as monotherapy or as adjunct therapy. The primary endpoint was the change in severity of sleep disturbances, assessed with the PD Sleep Scale from baseline to month 2. Exploratory endpoints included change in daytime sleepiness, assessed with the Epworth Sleep Scale, treatment satisfaction measured with the Treatment Satisfaction Questionnaire for Medication, patient’s overall improvement or deterioration over time measured with the Clinical Global Impression of Improvement, tolerability, and safety. Findings: Patients treated with rasagiline as mono- or adjunct therapy showed a statistically significant improvement in sleep quality after 2 months. There was no change in daytime sleepiness. Overall, patients were satisfied with rasagiline treatment with a mean Treatment Satisfaction Questionnaire for Medication [standard deviation] total score at month 2 of 68% [16.1]. At the end of study, 64 patients (65.9%) were judged, by the investigator, as being at least minimally improved from baseline on the Clinical Global Impression of Improvement. Rasagiline was safe and well-tolerated. Interpretation: Rasagiline as mono- or adjunct-therapy may improve sleep experience in patients with PD in the short term.

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The Effect of Rotigotine on Cognitive Function and Sleep Problems in Parkinson's Disease: an Open-Label Pilot Study

10.21203/rs.3.rs-138691/v1 ◽

2021 ◽

Author(s):

Keisuke Suzuki ◽

Kei Funakoshi ◽

Hiroaki Fujita ◽

Koichi Hirata

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Cognitive Function ◽

Daytime Sleepiness ◽

Sleep Disturbances ◽

Rating Scale ◽

Sleep Problems ◽

Motor Symptoms ◽

Open Label ◽

Updrs Part

Abstract Background: We hypothesized that rotigotine may have a positive effect on cognitive function in patients with Parkinson’s disease (PD) by improving daytime motor function and nighttime sleep status due to its 24-hour sustained properties.Methods: We evaluated the effect of rotigotine on motor symptoms, cognitive function, daytime sleepiness, sleep disturbances, and motor symptoms in 10 PD patients with sleep disturbances, defined as a PD Sleep Scale (PDSS)-2 score of ≥ 15, in a single-center, 3-month open-label study. Participants received 24 mg/24 h (patch content: 4.5-9 mg) rotigotine for a 3-month period. At baseline and 3 months, patients were evaluated on the Movement Disorder Society Revision of the Unified PD Rating Scale (MDS-UPDRS) parts III and IV and cognitive assessments, such as the Mini-Mental State Examination (MMSE), frontal assessment battery (FAB) and Montreal Cognitive Assessment (MoCA). The Epworth Sleepiness Scale (ESS) and PDSS-2 were administered at baseline and at 1 month, 2 months and 3 months.Results: At 3 months, MDS-UPDRS part III (-10.7, p<0.001) and MDS-UPDRS part IV (-1.0, p=0.023) scores significantly decreased, MoCA scores (1.7, p=0.0095) significantly increased, and off time significantly decreased (-43.0 min; p=0.029) from baseline. PDSS-2 scores significantly decreased from baseline at 2 months (-14.5, p<0.05) and 3 months (-20.0, p<0.001). ESS, MMSE or FAB scores did not significantly change after rotigotine treatment.Conclusion: Our preliminary findings suggest that low-dose rotigotine could improve motor symptoms, sleep disturbance, and cognitive function without worsening daytime sleepiness in patients with PD.

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High doses of pergolide improve clinical global impression in advanced Parkinson's disease—A preliminary open label study

Archives of Gerontology and Geriatrics ◽

10.1016/j.archger.2005.04.002 ◽

2005 ◽

Vol 41 (3) ◽

pp. 239-253 ◽

Cited By ~ 4

Author(s):

Guy Arnold ◽

Thomas Gasser ◽

Alexander Storch ◽

Axel Lipp ◽

Andreas Kupsch ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Clinical Global Impression ◽

Open Label ◽

Advanced Parkinson’S Disease ◽

Open Label Study ◽

Label Study ◽

High Doses

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Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease

npj Parkinson s Disease ◽

10.1038/s41531-021-00246-y ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Francesc Valldeoriola ◽

María José Catalán ◽

Francisco Escamilla-Sevilla ◽

Eric Freire ◽

Jesús Olivares ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Treatment Satisfaction ◽

Well Being ◽

Patient Treatment ◽

Motor Symptoms ◽

Serious Adverse Events ◽

Advanced Parkinson’S Disease ◽

Anxiety Depression ◽

The Impact

AbstractLevodopa-carbidopa intestinal gel (LCIG) has shown to be efficacious in motor and non-motor symptoms (NMS). Nevertheless, studies with patient Quality of Life (QoL) as a primary endpoint are scarce. To assess the effect of LCIG on Advanced Parkinson’s Disease (APD) patients QoL. Secondarily, the impact on motor symptoms and NMS, emotional well-being, treatment satisfaction, and caregiver QoL, stress, disease burden, anxiety, depression, and work impairment were also investigated. In this prospective, 6-month multicenter postmarketing observational study, LCIG was administered to 59 patients with APD. Endpoints were assessed using validated scales and questionnaires. LCIG significantly improved patient QoL (PDQ-39 mean change ± standard deviation from baseline, −12.8 ± 14.6; P < 0.0001), motor symptoms (UPDRS-III in “On,” −6.5 ± 11.8; P = 0.0002), NMS (NMSS, −35.7 ± 31.1; P < 0.0001), mood (Norris/Bond-Lader VAS, −6.6 ± 21.1; P = 0.0297), fatigue (PFS-16, −0.6 ± 1.0; P = 0.0003), depression (BDI-II, −5.1 ± 9.4; P = 0.0002), anxiety (BAI, −6.2 ± 9.6; P < 0.0001), and patient treatment satisfaction (SATMED-Q, 16.1 ± 16.8; P < 0.0001). There were significant correlations between the change from baseline to 6 months between PDQ-39 and UPDRS-IV, NMSS, BAI, BDI-II, AS, and PFS-16 scores, and Norris/Bond-Lader alertness/sedation factor. Caregiver anxiety also improved (Goldberg anxiety scale, −1.1 ± 1.0; P = 0.0234), but the clinical relevance of this finding is questionable. The serious adverse events reported were similar to those previously described for LCIG. In patients with APD, LCIG improves QoL, motor symptoms and NMS, emotional well-being, and satisfaction with the treatment. Improvement in patient QoL is associated with improvements in motor complications, NMS, anxiety, depression, apathy and fatigue. Improvements in patients’ QoL does not correspond with improvements in caregivers’ QoL or burden.

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INFLUENCE OF SLEEP DISTURBANCES ON COGNITIVE DECLINE IN PATIENTS WITH PARKINSON’S DISEASE

Ukrainian Scientific Medical Youth Journal ◽

10.32345/usmyj.3(117).2020.58-67 ◽

2020 ◽

Vol 117 (3) ◽

pp. 58-67

Author(s):

Anastasiia Shkodina ◽

Kateryna Tarianyk ◽

Dmytro Boiko

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Cognitive Impairment ◽

Cognitive Decline ◽

Sleep Disorders ◽

Sleep Disturbances ◽

Rating Scale ◽

Early Stages ◽

The Impact

The article summarizes the arguments and counter-arguments within the scientific discussion on the impact of sleep disorders on the development of cognitive decline in patients with Parkinson's disease. The main purpose of the study is to study the possibility of predicting the development of cognitive decline by assessing the severity of sleep disorders and their differences in the presence of cognitive impairment. Systematization of literature sources and approaches to solving the problem showed that sleep disorders develop in the early stages of Parkinson's disease and are often accompanied by cognitive impairment. Cognitive decline is manifested throughout Parkinson's disease and ranges from moderate in the early stages to dementia in the late stages. The relevance of the study of the relationship between sleep disorders and cognitive functions lies in the possibility of further improving the prediction of the development of cognitive decline in order to effectively correct it. Treatment of sleep disorders can be accompanied by improved memory and even morphological changes in the brain. Therefore, the question arises about the possibility of correcting cognitive decline by influencing sleep disorders. The methodology of the study included assessment of the overall status of patients on a unified scale of Parkinson's disease, Montreal cognitive rating scale and sleep scale in Parkinson's disease. The duration of the study was 8 months. Patients with Parkinson's disease were selected as the study. The article presents the results of a survey of patients who show that patients with Parkinson's disease and cognitive decline showed a predominance of motor disorders, sleep disorders and the overall score on the sleep scale in Parkinson's disease. In the presence of cognitive decline more pronounced disorders of motor functions in everyday life, which can lead to sleep disorders and its quality. The study empirically confirms and theoretically proves that the assessment of sleep disorders can be used to predict the risk of developing cognitive impairment in patients with Parkinson's disease. The results of this study may be useful for improving the early diagnosis and prevention of cognitive impairment in patients with Parkinson's disease, which, in turn, leads to improved quality of treatment of these patients. Such changes can directly affect the choice of therapeutic tactics and improve the quality of life of patients with Parkinson's disease. The question of the features of various sleep disorders and their prognostic value in relation to cognitive decline in patients with various forms of Parkinson's disease remains open.

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Rotigotine Objectively Improves Sleep in Parkinson’s Disease: An Open-Label Pilot Study with Actigraphic Recording

Parkinson s Disease ◽

10.1155/2016/3724148 ◽

2016 ◽

Vol 2016 ◽

pp. 1-5 ◽

Cited By ~ 6

Author(s):

Giovanna Calandra-Buonaura ◽

Pietro Guaraldi ◽

Andrea Doria ◽

Stefano Zanigni ◽

Stefania Nassetti ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Pilot Study ◽

Motor Activity ◽

Sleep Quality ◽

Sleep Disturbances ◽

Open Label ◽

Sleep Complaints ◽

Objective Evidence ◽

Rotigotine Treatment

Sleep disturbances represent important predictors of poor quality of life (QoL) in Parkinson’s disease (PD). This open-label pilot study aimed to objectively assess, by means of actigraphic recording, effect of rotigotine on sleep in PD patients with self-reported sleep complaints. 15 PD patients underwent one-week actigraphic recording before (T0) and during (T1) rotigotine treatment, which was titrated to the dose subjectively improving motor symptoms (4–8 mg/24 h). Sleep disturbances, daytime sleepiness, cognitive performance, QoL, and depression were also evaluated with questionnaires. Actigraphic recordings showed a significant reduction in nocturnal motor activity and mean duration of wake episodes after sleep onset during rotigotine treatment compared to baseline. In 10 patients presenting objective evidence of poor sleep quality at T0 (sleep efficiency ≤ 85%), rotigotine also significantly improved other sleep parameters and further reduced nocturnal motor activity and mean duration of wake episodes. A significant decrease in number and duration of daytime sleep episodes was also observed at T1. Finally we confirmed that rotigotine significantly improves perceived sleep quality and QoL. Our study showed for the first time that rotigotine is associated with an objective improvement of nocturnal and diurnal sleep disturbances in PD patients with self-reported sleep complaints. This study is registered with AIFA-observational study registry number 12021.

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

Parkinson s Disease ◽

10.1155/2015/475630 ◽

2015 ◽

Vol 2015 ◽

pp. 1-6 ◽

Cited By ~ 3

Author(s):

Francesc Vallderiola ◽

Yaroslau Compta ◽

Javier Aparicio ◽

Jaume Tarradellas ◽

Gabriel Salazar ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Sleep Disturbances ◽

Short Form ◽

Early Morning ◽

Open Label ◽

Night Time ◽

Open Label Study ◽

End Of Treatment

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.

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Selegiline Improves Excessive Daytime Sleepiness in Parkinson’s Disease: An Open Trial

10.21203/rs.3.rs-708038/v1 ◽

2021 ◽

Author(s):

Jinru Zhang ◽

Ju-ping Chen ◽

Jia Li ◽

Jian Li ◽

Hong Miao ◽

...

Keyword(s):

Quality Of Life ◽

Parkinson’S Disease ◽

Parkinson's Disease ◽

Excessive Daytime Sleepiness ◽

Daytime Sleepiness ◽

Motor Fluctuation ◽

Life Questionnaire ◽

Open Label ◽

Multi Center Study

Abstract Excessive daytime sleepiness (EDS) is common in Parkinson’s disease (PD) and may respond to dopaminergic therapies. The aim of this open-label trial was to assess the efficacy and safety of selegiline as a treatment for EDS in PD patients. In this multi-center study, 141 PD subjects were enrolled between December 2019 and October 2020, and 121 patients completed the 8-week study. Selegiline was administered at 5 mg/day in the first week and was increased to 10 mg per day during the following weeks. EDS was evaluated using the Epworth Sleepiness Scale (ESS) at baseline, week 3, and week 8. Changes in motor complications, sleep quality, and quality of life were also assessed in patients with PD. As primary outcomes, ESS scores decreased significantly in PD patients who received selegiline for 8 weeks (P < 0.001). As secondary outcomes, the scores of Parkinson's disease sleep scale (PDSS) and Parkinson’s disease quality of life questionnaire 39 (PDQ-39) also improved after the treatment. The severity of motor fluctuation improved (P=0.037), while the percentage of patients with dyskinesia and the severity of dyskinesia did not increase significantly compared with baseline. Participants treated with selegiline showed an improvement in EDS and good tolerance of the drug. This study demonstrated the efficacy of selegiline for the treatment of daytime sleepiness in PD patients.Trial registration: clinicaltrials, NCT04870372. Registered 5 May 2021 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009J06&selectaction=Edit&uid=U00026CP&ts=2&cx=ruz8uy.

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