Objective: Assess the impact of foscarbidopa/foslevodopa (CDp/LDp) continuous subcutaneous infusion (CSCI) on the motor states of people with Parkinson’s disease (PD) across 24 hours via heat map visualization.

Background: An active-controlled, randomized, double-blind phase 3 trial (NCT04380142) showed significant improvement in Good ON time (ON time without troublesome dyskinesia) of mean (SE) 2.72 (0.52) hours (vs 0.97 [0.50] hours with oral carbidopa/levodopa therapy) after 12 weeks of 24-hour/day CDp/LDp CSCI treatment.[1] Significant Good ON time improvements were seen in an open-label, 52-week, single-arm phase 3 trial (NCT03781167)[2]; and sustained improvements in interim results from an open-label 96-week extension (NCT04750226)[3] of the above active-controlled trial.

Method: In patients treated with CDp/LDp in the above active-controlled trial or pooled across the 3 trials, their Baseline and Week 12 motor state data from the PD Hauser diaries were individually visualized on heat maps. Patient data from 7.5 hours prior to awakening to 16 hours after waking up was categorized as either: Best ON time (ON time without dyskinesia), ON time with troublesome dyskinesia, ON time with non-troublesome dyskinesia, OFF time, Asleep, or Missing.

Results: Overall quantitative improvements observed at Week 12 in both the active-controlled and pooled trials included: increased Best ON time duration (light green color), a more consistent/homogeneous Best ON time experience across the trial samples, with less observed fragmentation of the day into smaller ON time blocks, and a decreased amount of OFF time (blue) exhibited across the sample [figure1][figure2]. Overall CDp/LDp treatment safety from these trials was previously reported as generally well tolerated.[1][2][3]

Conclusion: Based on the heat maps of the individual PD diary days, CDp/LDp-treated patients were observed to have improvements in hours and continuous durations of Best ON time and less fragmented/more homogenous reporting of motor states across the 24-hour day.

Figure 1

Figure 2

References: [1] Soileau MJ, et al. Lancet Neuro. 2022;21:1099–1109.
[2] Aldred J, et al. Neurol Ther. 2023;12(6):1937-1958.
[3] Hauser R, et al. Mov Disord. 2024;39(Suppl 1; Abstract 693):S317-318.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/heat-map-visualization-of-improved-best-on-time-in-people-with-parkinsons-disease-treated-with-foscarbidopa-foslevodopa/