ArticleNeurology and therapy2023
Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study.
Article in Neurology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 91 papers, 6 of them syntheses 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.
A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease
A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients
Who cites it
91 citing papers in PubMed, 6 syntheses or guidelines pooled it, 94 citations in OpenAlex.
- Pooled it
- Subcutaneous Levodopa in Parkinson's Disease: A Systematic Review and Meta-Analysis.European journal of neurology · 2026Pooled it
- Effects of deep brain stimulation on non-motor symptoms in Parkinson's disease: insights from longitudinal studies using consistent evaluation scales.Journal of neurology · 2026Pooled it
- Nocturnal Hypokinesia and Early Morning OFF in Parkinson's Disease: State-of-the-Art and Systematic Review of Treatment Availability.Current neurology and neuroscience reports · 2025Pooled it
- Invasive therapies for Parkinson's disease: an adapted excerpt from the guidelines of the German Society of Neurology.Journal of neurology · 2025Pooled it
- How well is the female population represented in clinical trials with infusion therapies for Parkinson's disease? A systematic review and metanalysis.European journal of neurology · 2025Pooled it
- Foslevodopa/Foscarbidopa Subcutaneous Infusion Safety and Efficacy in Patients with and Without Prior Deep Brain Stimulation.Advances in therapy · 2026Trial
- Efficacy and Safety of Foslevodopa/Foscarbidopa Monotherapy in Patients with Parkinson's Disease.Movement disorders clinical practice · 2026Trial
- Patients' experience with and perspectives on long-term use of continuous subcutaneous infusion of foslevodopa/foscarbidopa in Parkinson's disease.Journal of neurology · 2025Trial
- Improved Sleep Correlates with Improved Quality of Life and Motor Symptoms with Foslevodopa/Foscarbidopa.Movement disorders clinical practice · 2024Trial
- 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
- Continuous infusion therapy after deep brain stimulation in Parkinson's disease: indications, outcomes, and patient selection.Journal of neural transmission (Vienna, Austria : 1996) · 2026Review
- Real-world neuropsychiatric safety profile of foslevodopa/foscarbidopa infusion in advanced Parkinson's disease.Journal of neurology · 2026Article
- Real-world experience with foslevodopa/foscarbidopa in Germany: therapeutic insights and lessons learned.Neurological research and practice · 2026Review
- Global research synergy: Advancing fundamental Parkinson's research through international collaboration.Journal of Parkinson's disease · 2026Review
- Continuous Subcutaneous Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease.Movement disorders clinical practice · 2026Article
- Gastroparesis in Parkinson's disease: Diagnostic and clinical implications for optimizing pharmacological treatment.Journal of Parkinson's disease · 2026Review
- Review
- 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 Safety and Effectiveness of 24-Hour Foslevodopa/Foscarbidopa in Parkinson's Disease: ROSSINI Study 6-Month Interim Results.Neurology and therapy · 2026Article
31 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
22 authors at 17 institutions in 12 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionFoslevodopa/foscarbidopa, a soluble formulation of levodopa/carbidopa (LD/CD) prodrugs for the treatment of Parkinson's disease (PD), is administered as a 24-hour/day continuous subcutaneous infusion (CSCI) with a single infusion site. The efficacy and safety of foslevodopa/foscarbidopa versus oral immediate-release LD/CD was previously demonstrated in patients with PD in a 12-week, randomized, double-blind, phase 3 trial (NCT04380142). We report the results of a separate 52-week, open-label, phase 3 registrational trial (NCT03781167) that evaluated the safety/tolerability and efficacy of 24-hour/day foslevodopa/foscarbidopa CSCI in patients with advanced PD.
methodsMale and female patients with levodopa-responsive PD and ≥ 2.5 hours of "Off" time/day received 24-hour/day foslevodopa/foscarbidopa CSCI at individually optimized therapeutic doses (approximately 700-4250 mg of LD per 24 hours) for 52 weeks. The primary endpoint was safety/tolerability. Secondary endpoints included changes from baseline in normalized "Off" and "On" time, percentage of patients reporting morning akinesia, Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Parkinson's Disease Sleep Scale-2 (PDSS-2), 39-item Parkinson's Disease Questionnaire (PDQ-39), and EuroQol 5-dimension questionnaire (EQ-5D-5L).
resultsOf 244 enrolled patients, 107 discontinued, and 137 completed treatment. Infusion site events were the most common adverse events (AEs). AEs were mostly nonserious (25.8% of patients reported serious AEs) and mild/moderate in severity. At week 52, "On" time without troublesome dyskinesia and "Off" time were improved from baseline (mean [standard deviation (SD)] change in normalized "On" time without troublesome dyskinesia, 3.8 [3.3] hours; normalized "Off" time, -3.5 [3.1] hours). The percentage of patients experiencing morning akinesia dropped from 77.7% at baseline to 27.8% at week 52. Sleep quality (PDSS-2) and quality of life (PDQ-39 and EQ-5D-5L) also improved.
conclusionFoslevodopa/foscarbidopa has the potential to provide a safe and efficacious, individualized, 24-hour/day, nonsurgical alternative for patients with PD. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT03781167.
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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.