3482 Correlation between sleep and quality of life in people with parkinson’s disease treated with continuous subcutaneous infusion of foslevodopa/foscarbidopa

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Objectives To assess the correlation between sleep and quality of life (QoL) in people with Parkinson’s disease (PwP) receiving either oral levodopa/carbidopa immediate-release (LD/CD-IR) tablets or continuous subcutaneous infusion (CSCI) of foslevodopa/foscarbidopa (LDp/CDp) for 12 weeks.Methods This post hoc analysis evaluated sleep responders (PwP demonstrating clinically meaningful PDSS-2 total score [TS] improvement of ≥-3.44 change from BL to week 12 [wk-12]) in the LDp/CDp vs oral LD/CD-IR treatment arms of a 12-week phase 3 trial. Sleep responders LS mean (SE) PDQ-39 and ADL changes from BL were compared within and between arms. Pearson’s correlation coefficient was calculated in the full analysis set. All reported P values were nominal with no multiplicity corrections.Results The 12-week trial full analysis set had significantly more sleep responders in the LDp/CDp (n=32/44 with existing data, P<.01, 73%) vs oral (n=25/59 with existing data, 42%) arms. Sleep responder PDQ-39/ADL changes from BL showed no significant differences between arms. A significant moderate positive correlation between PDSS-2 TS and PDQ-39 Summary Index was seen in all LDp/CDp-treated PwP at BL and wk-12, with consistently positive correlation data across QoL/ADL measures. The 12-week trial safety profile showed LDp/CDp CSCI was well tolerated and generally safe.Conclusion The LDp/CDp arm had significantly more sleep responders vs the oral arm, and sleep responders demonstrated significant QoL improvements from BL in both groups. No confounding correlations were observed and significant weak to moderate positive correlations between sleep and QoL/ADL were seen in the full analysis set in both arms.

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