Objective: To investigate the relationship between improvements in sleep disturbances and quality of life (QoL) in adults with advanced Parkinson’s disease (aPD) treated with a continuous subcutaneous infusion of foslevodopa/foscarbidopa (LDp/CDp).

Background: LDp/CDp is a 24-hour/day infusion of levodopa and carbidopa prodrugs. While data from clinical trials support the safety and efficacy of LDp/CDp, further insights are needed to better understand its impact on sleep.

Method: This post hoc analysis used data from adults with aPD treated with LDp/CDp in 2 phase 3 clinical trials: a 12-week randomized controlled trial (RCT, NCT04380142) and a 52-week open-label safety trial (OLST, NCT03781167). Participants were included if they had a Parkinson’s Disease Sleep Scale (PDSS-2) score ≥ 18 at baseline and had nonmissing PDSS‑2 data at week 12 (RCT) or week 52 (OLST) to determine if their score improved to < 18. PDSS-2 assesses sleep disturbances on a scale of 0 (no disturbance) to 60 (severe nocturnal disturbances),[1,2] and scores ≥ 18 are considered to indicate clinically relevant sleep disturbances.[3,4] Additionally, QoL improvement was assessed as decreases in Parkinson’s Disease Questionnaire-39 (PDQ-39) score, which ranges from 0 (no impact of Parkinson’s on QoL) to 100 (severe impact).[5,6]

Results: Over half of participants with a PDSS‑2 score ≥ 18 at baseline experienced a reduction to < 18 (14/25, 56.5% at week 12 in the RCT; 54/78, 69.2% at week 52 in the OLST). In these participants, mean (standard deviation) PDQ‑39 scores improved from 35.2 (17.0) at baseline to 21.3 (12.1) at week 12 in the RCT (13.9-point decrease, 0.94 effect size) and improved from 37.4 (14.4) to 26.2 (16.5) at week 52 in the OLST (11.2-point decrease, 0.73 effect size). There was a statistically significant association between PDSS-2 and PDQ-39 score improvement (minimal clinically important difference of at least 3.44 and 4.72 points, respectively), where a greater percentage of RCT participants with PDSS-2 improvement also had PDQ-39 improvement (14/21 = 66.7%) than those without PDSS-2 improvement (0/4 = 0%; P = .026). The OLST had a nonsignificant trend in the same direction (69.2% vs 46.2%, P = .110).

Conclusion: The results suggest that improvements in sleep with LDp/CDp treatment for aPD are associated with QoL improvement.

References: 1. Chaudhuri KR, et al. J Neurol Neurosurg Psychiatry. 2002; 73(6):629–635.
2. Trenkwalder C, et al. Mov Disord. 2011; 26(4):644–652.
3. Muntean ML, et al. Sleep Med. 2016; 24:87–92.
4. Liguori C, et al. Sleep Med. 2021; 81:307–311.
5. Jenkinson C, et al. Age Ageing. 1995; 24(6):505–509.
6. Peto V, et al. Qual Life Res. 1995; 4(3):241–8.
7. Jenkinson C, et al. Age Ageing. 1997; 26(5):353–357.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/positive-relationship-between-improvement-in-sleep-and-quality-of-life-during-foslevodopa-foscarbidopa-continuous-subcutaneous-infusion/