Efficacy and Safety of Foslevodopa/Foscarbidopa Monotherapy in Patients with Parkinson's Disease
Bibliographic record
Abstract
BACKGROUND: As Parkinson's disease (PD) progresses, managing symptoms becomes increasingly difficult. Foslevodopa/foscarbidopa (LDp/CDp), a 24-hour/day continuous subcutaneous infusion of levodopa/carbidopa (LD/CD) prodrugs, improves motor complications. The feasibility and sustainability of LDp/CDp monotherapy warrants investigation. OBJECTIVE: The aim was to report the efficacy and safety of LDp/CDp monotherapy and combination therapy. METHODS: This post hoc analysis assessed patients with PD and ≥2.5 "Off" hours/day receiving LDp/CDp monotherapy or combination therapy in 3 trials: a 12-week randomized active-controlled trial (RCT) comparing LDp/CDp with oral immediate-release LD/CD (NCT04380142), a 52-week open-label trial of LDp/CDp (NCT03781167), and its 96-week open-label extension study (OLE; NCT04379050). Monotherapy was defined as receiving LDp/CDp without concomitant PD medications; combination therapy was defined as receiving LDp/CDp with other PD medications. RESULTS: In the RCT, 74 of 141 patients received LDp/CDp. The 52-week trial enrolled 244 patients; 129 entered the OLE. Of LDp/CDp-treated patients, 19 of 74 (25.7%) in the RCT, 49 of 244 (20.1%) in the 52-week trial, and 46 of 129 (35.7%) in the OLE received monotherapy. In the RCT, mean (standard deviation) change from baseline to week 12 in "Off" time was -4.5 (4.4) and -3.0 (3.5) hours for monotherapy and combination therapy, respectively; +4.1 (3.7) and +3.1 (3.6) hours for "On" time without troublesome dyskinesia; and +4.0 (3.6) and +4.0 (3.9) hours for "On" time without dyskinesia. Efficacy was similar in open-label trials. Improvements in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part II, 39-item Parkinson's Disease Questionnaire, Parkinson's Disease Sleep Scale-2 scores, and overall safety were comparable between monotherapy and combination therapy groups. CONCLUSIONS: LDp/CDp monotherapy treatment may be suitable for up to 96 weeks.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".