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Clinical Trial
. 2024 Jul;11(7):861-866.
doi: 10.1002/mdc3.14018. Epub 2024 Mar 11.

Improved Sleep Correlates with Improved Quality of Life and Motor Symptoms with Foslevodopa/Foscarbidopa

K Ray Chaudhuri  1   2 , Maurizio F Facheris  3 , Bruno Bergmans  4   5 , Filip Bergquist  6   7 , Susan R Criswell  8 , Jia Jia  3 , Pavnit Kukreja  3 , Yohei Mukai  9 , Amy M Spiegel  3 , Resmi Gupta  3 , Lars Bergmann  3 , Rajesh Pahwa  10
Affiliations
Clinical Trial

Improved Sleep Correlates with Improved Quality of Life and Motor Symptoms with Foslevodopa/Foscarbidopa

K Ray Chaudhuri et al. Mov Disord Clin Pract. 2024 Jul.

Abstract

Background: Foslevodopa/foscarbidopa is a subcutaneous infusion of levodopa/carbidopa prodrugs.

Objectives: Assess correlations between sleep and efficacy from interim data of a phase 3 trial of foslevodopa/foscarbidopa (NCT03781167).

Methods: Pearson correlations between sleep (Parkinson's Disease Sleep Scale-2 [PDSS-2]) and quality of life (QoL; Parkinson's Disease Questionnaire-39), motor experiences of daily living (m-EDL; Movement Disorder Society-Unified Parkinson's Disease Scale Part II), and "Off"/"On" times were calculated for baseline and week 26 improvements. Regression analyses were adjusted for baseline PDSS-2 score.

Results: Baseline sleep correlated moderately with QoL (r = 0.44, P < 0.001) and weakly with m-EDL (r = 0.28; P < 0.001). Sleep improvement weakly correlated with improved "Off" time (r = 0.37; P < 0.001) and QoL (r = 0.36; P < 0.001). Regression analyses demonstrated significant positive associations for improved sleep, "Off" time, QoL, and m-EDL.

Conclusions: Improved sleep with foslevodopa/foscarbidopa was associated with improved QoL and "Off" time.

Keywords: Parkinson's disease; foslevodopa/foscarbidopa; infusion therapy; post hoc analysis; sleep.

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Figures

Figure 1
Figure 1
Correlations of sleep (PDSS‐2) and “On” and “Off” times (based on PD diaries), motor experiences of daily living (MDS‐UPDRS Part II), and quality of life (PDQ‐39) at baseline. a95% prediction ellipse. bPearson correlation coefficient vs. PDSS‐2. ***P < 0.0001. m‐EDL, motor experiences of daily living; MDS‐UPDRS Part II, Movement Disorder Society‐Unified Parkinson's Disease Rating Scale Part II; PDQ‐39, 39‐item Parkinson's Disease Questionnaire; PDSS‐2, Parkinson's Disease Sleep Scale‐2; QoL, quality of life.
Figure 2
Figure 2
Correlations of improvement from baseline to week 26 in sleep (PDSS‐2) and improvements in “On” and “Off” times (based on PD diaries), improvements in motor experiences of daily living (MDS‐UPDRS Part II), and improvements in quality of life (PDQ‐39) following treatment with 24‐hour/day foslevodopa/foscarbidopa CSCI. a95% prediction ellipse. bPearson correlation coefficient vs. change in PDSS‐2. ***P < 0.001. *P < 0.05. β̂ values are from a linear regression model adjusted for baseline PDSS‐2. CI, confidence interval; CSCI, continuous subcutaneous infusion; m‐EDL, motor experiences of daily living; MDS‐UPDRS Part II, Movement Disorder Society‐Unified Parkinson's Disease Rating Scale Part II; PDQ‐39, 39‐item Parkinson's Disease Questionnaire; PDSS‐2, Parkinson's Disease Sleep Scale‐2; QoL, quality of life.
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