Post hoc exploratory analysis of the effect of foslevodopa/foscarbidopa continuous subcutaneous infusion on nocturia in patients with Parkinson’s disease
Bibliographic record
Abstract
Introduction: Parkinson's disease (PD) non-motor symptom burden, including nocturia and sleep disturbances, worsens with disease progression. Continuous dopaminergic drug delivery with nocturnal infusion in PD demonstrated improvements in sleep and nocturia. Foslevodopa/foscarbidopa (LDp/CDp) provides 24-hour continuous drug delivery of levodopa/carbidopa (LD/CD) prodrugs via continuous subcutaneous infusion (CSCI). Methods: Least-squares mean nocturia changes (measured via Parkinson's Disease Sleep Scale-2 item 8) in patients with PD from a randomized 12-week phase 3 trial of LDp/CDp CSCI versus oral LD/CD (NCT04380142) and a 52-week open-label LDp/CDp CSCI phase 3 trial (NCT03781167) were analyzed post hoc via mixed-effects regression and analysis of covariance. Correlation coefficients at baseline (BL) and in change from BL to week 12 or week 52 (Δ BL-wk 12 or Δ BL-wk 52) for nocturia and quality of life (QoL, measured as Parkinson's Disease Questionnaire [PDQ-39] Summary Index score) were calculated via Spearman's test. Results: This exploratory analysis demonstrated significant and sustained improvement in nocturia symptoms from BL with LDp/CDp treatment in both the randomized (to week 12; n = 44; nominal p ≤ 0.01) and open-label (to weeks 6, 13, 26, and 52; with n = 176, 149, 107, and 75, respectively; nominal p ≤ 0.001 for all) trials. Nocturia improvement was significantly greater in LDp/CDp- versus oral-treated patients (n = 59; nominal p ≤ 0.05). A significant positive correlation between nocturia and QoL was shown at BL and between Δ BL-wk 12 in the randomized trial (nominal p ≤ 0.05 for both), while open-label results showed no significant correlations. Conclusions: LDp/CDp-treated patients with PD demonstrated significantly improved nocturia with 24-hour therapy, 12-week nocturia improvements were significantly greater than oral therapy, and patient-reported nocturia may correlate with QoL.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".