ArticleNeurology and therapy2026
Real-World Safety and Effectiveness of 24-Hour Foslevodopa/Foscarbidopa in Parkinson's Disease: ROSSINI Study 6-Month Interim Results.
Article in Neurology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-label Extension of Study M15-741 to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease
An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson's Disease
A Global Real-World Evidence Study on the Long-term Effectiveness of ABBV-951 in Advanced Parkinson´s Disease in Routine Clinical Practice (ROSSINI: Real-world Outcomes With continuouS Subcutaneous Levodopa INfusIon)
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Characteristics and Hospitalization Details of Patients with Advanced Parkinson's Disease Receiving Continuous Subcutaneous Infusion of Foslevodopa/Foscarbidopa: Real-World First-Year Descriptive Study from Japan.Neurology and therapy · 2026Article
- Real-world experience with foslevodopa/foscarbidopa in Germany: therapeutic insights and lessons learned.Neurological research and practice · 2026Review
- Continuous Subcutaneous Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease.Movement disorders clinical practice · 2026Article
- Observational Retrospective Cohort of Patient Support Program Data on Practical Experiences of Treatment with Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease: The ORCHESTRA Study.Neurology and therapy · 2026Article
- Real-world implementation of continuous subcutaneous foslevodopa/foscarbidopa in advanced Parkinson's disease: first clinical experience from the Middle East.Therapeutic advances in neurological disorders · 2026Article
- Continuous subcutaneous foslevodopa/foscarbidopa in advanced Parkinson's disease: A clinical workflow from 50 consecutive patients at a single U.S. center.Clinical parkinsonism & related disorders · 2026Article
- Refractory gastrointestinal symptoms improved with transition to continuous subcutaneous Foslevodopa/Foscarbidopa infusion in advanced Parkinson's disease.Clinical parkinsonism & related disorders · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionFoslevodopa/foscarbidopa (LDp/CDp) is a nonsurgical 24-h continuous subcutaneous infusion for patients with advanced Parkinson's disease (aPD) and motor fluctuations uncontrolled on oral medications. We present the first multicountry real-world data from routine clinical practice.
methodsROSSINI (NCT06107426) is an ongoing 3-year multicountry, prospective, observational study of adults with aPD who are LDp/CDp-naïve (cohort A) or transitioning from LDp/CDp open-label extension studies (NCT04379050/NCT04750226, cohort B). For this interim analysis, the primary endpoint was change from baseline to 6 months in OFF time [Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV (MDS-UPDRS-IV) modified item 4.3]. Safety was assessed by monitoring adverse events (AEs). Interim results for 105 cohort A patients enrolled ≥ 6 months by March 24, 2025 are presented only; cohort B results were limited (n = 5). Mixed-effects models for repeated measurements (continuous outcomes) were utilized, adjusted for country.
resultsCohort A patients had a mean (SD) age of 68.5 (9.5) years, PD duration of 12.1 (5.3) years, and least squares mean (SE) OFF time of 5.2 (0.6) h at baseline. Patients on LDp/CDp showed statistically significant reductions (95% CI) in OFF time [(- 2.8 h (- 3.6, - 1.9), P ≤ .001, n = 47/40 at baseline/month 6], dyskinesia time [- 1.8 h (- 2.6, - 0.9), P ≤ 0.001], MDS-UPDRS-III [- 5.0 (- 8.2, - 1.9), P = 0.002], Parkinson's Disease Sleep Scale-2 [- 5.2 (- 8.0, - 2.4), P ≤ .001], and 39-item Parkinson's Disease Questionnaire [PDQ-39, - 5.6 (- 9.2, - 2.0), P = .002] from baseline to month 6. Freezing of Gait Questionnaire, Gastrointestinal Dysfunction Scale in PD, and King's PD Pain Scale likewise showed statistically significant decreases (P < .05). Overall, 58 (55.2%) reported ≥ 1 AE, primarily nonserious and mild-to-moderate (12.4% serious, 17.1% severe), with hallucinations and infusion site events the most frequently reported events (5.7% each).
conclusionsROSSINI demonstrates reductions in motor fluctuations and nonmotor symptoms, and increased quality of life in patients with aPD after 6 months of LDp/CDp treatment. The safety profile was consistent with clinical trials.
trial registrationClinicalTrials.gov identifier, NCT06107426.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.