Trial reportJournal of Parkinson's disease2021
Foslevodopa/Foscarbidopa Is Well Tolerated and Maintains Stable Levodopa and Carbidopa Exposure Following Subcutaneous Infusion.
Trial report in Journal of Parkinson's disease, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
46 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- Subcutaneous Levodopa in Parkinson's Disease: A Systematic Review and Meta-Analysis.European journal of neurology · 2026Pooled 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
- Improved Sleep Correlates with Improved Quality of Life and Motor Symptoms with Foslevodopa/Foscarbidopa.Movement disorders clinical practice · 2024Trial
- Metabolite profiling of foslevodopa/foscarbidopa in plasma of healthy human participants by LC-HRMS indicates no major differences compared to administration of levodopa/carbidopa intestinal gel.Pharmacology research & perspectives · 2024Trial
- 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
- Continuous Subcutaneous Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease.Movement disorders clinical practice · 2026Article
- Plasma 3-O-Methyldopa Concentration Monitoring for Treatment Optimization in Foslevodopa/Foscarbidopa Infusion: Implications for Corrected Levodopa Availability: A Case Report.Movement disorders clinical practice · 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
- Is continuous dopaminergic delivery still a major goal to be achieved in the treatment of Parkinson's disease?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
- Effect of continuous subcutaneous foslevodopa/foscarbidopa infusion on gait in advanced Parkinson's disease: a real-world wearable-based study.Journal of neurology · 2026Article
- Device aided therapies in Parkinson disease: an expert view on apomorphine.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Review
- Continuous Subcutaneous Versus Intestinal Levodopa Infusion for Parkinson's Disease: A Real-World, Monocentric, Observational Study and Critical Review.Movement disorders clinical practice · 2026Observational
- Considerations for Initiation and Maintenance of Foslevodopa/Foscarbidopa for Advanced Parkinson's Disease.Movement disorders clinical practice · 2026Review
- Opicapone as Add-On Therapy to Continuous Subcutaneous Foslevodopa/Foscarbidopa Infusion: Clinical Improvement and Wearable Sensor-Based Gait Analysis.Brain sciences · 2026Article
- Foslevodopa-Foscarbidopa subcutaneous infusion in Parkinson's disease: a cross-cultural/cross-racial international multicentre comparative tolerability study (CRIM-FOS study).Scientific reports · 2026Article
- Multiple aseptic cellulitis following continuous subcutaneous injection of foslevodopa-foscarbidopa: Two case reports.JAAD case reports · 2026Article
- Advanced Therapeutics in Parkinson's Disease: What's New?Current neurology and neuroscience reports · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFoslevodopa/foscarbidopa, formerly known as ABBV-951, is a formulation of levodopa/carbidopa prodrugs with solubility that allows for subcutaneous (SC) infusion and is in development for the treatment of motor complications for patients with advanced Parkinson's disease (aPD).
objectiveThe current work characterizes the levodopa (LD) and carbidopa (CD) pharmacokinetics (PK) following SC infusions of foslevodopa/foscarbidopa delivered at four different infusion rates in PD patients.
methodsThis was a Phase 1, single ascending dose, single-blind study conducted in 28 adult male and female subjects at seven sites in the United States. Foslevodopa/foscarbidopa was administered via abdominal SC infusion in PD patients over 72 hours. Patients were stratified in 4 groups and received a fixed dose of foslevodopa/foscarbidopa based on their oral daily LD intake. Serial plasma PK samples were collected to assay for LD and CD concentrations. Safety and tolerability were assessed throughout the study.
resultsLD exposure quickly reached steady state and remained stable with minimal fluctuations. Foslevodopa/foscarbidopa infusion provides stable LD and CD exposures compared to oral LD/CD dosing with the average steady-state exposure ranging from 747-4660 ng/mL for the different groups.
conclusionFoslevodopa/foscarbidopa was able to provide stable LD and CD exposures in PD patients over 72 hours via SC route of delivery with very low fluctuation in LD concentration level across a wide range of clinically relevant exposures. Foslevodopa/foscarbidopa had a favorable safety profile. The low PK fluctuation following foslevodopa/foscarbidopa infusion is expected to maintain LD exposure to treat aPD patients within a narrow therapeutic window.
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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.