25 research outputs found
Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinsonâs Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study
\ua9 2023, The Author(s). Introduction: Foslevodopa/foscarbidopa, a soluble formulation of levodopa/carbidopa (LD/CD) prodrugs for the treatment of Parkinsonâs 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. Methods: Male and female patients with levodopa-responsive PD and â„ 2.5 hours of âOffâ time/day received 24-hour/day foslevodopa/foscarbidopa CSCI at individually optimized therapeutic doses (approximately 700â4250 mg of LD per 24 hours) for 52 weeks. The primary endpoint was safety/tolerability. Secondary endpoints included changes from baseline in normalized âOffâ and âOnâ time, percentage of patients reporting morning akinesia, Movement Disorder Society Unified Parkinsonâs Disease Rating Scale (MDS-UPDRS), Parkinsonâs Disease Sleep Scaleâ2 (PDSS-2), 39-item Parkinsonâs Disease Questionnaire (PDQ-39), and EuroQol 5-dimension questionnaire (EQ-5D-5L). Results: Of 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, âOnâ time without troublesome dyskinesia and âOffâ time were improved from baseline (mean [standard deviation (SD)] change in normalized âOnâ time without troublesome dyskinesia, 3.8 [3.3] hours; normalized âOffâ time, â3.5 [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. Conclusion: Foslevodopa/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
QCD and strongly coupled gauge theories : challenges and perspectives
We highlight the progress, current status, and open challenges of QCD-driven physics, in theory and in experiment. We discuss how the strong interaction is intimately connected to a broad sweep of physical problems, in settings ranging from astrophysics and cosmology to strongly coupled, complex systems in particle and condensed-matter physics, as well as to searches for physics beyond the Standard Model. We also discuss how success in describing the strong interaction impacts other fields, and, in turn, how such subjects can impact studies of the strong interaction. In the course of the work we offer a perspective on the many research streams which flow into and out of QCD, as well as a vision for future developments.Peer reviewe
Correction: Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinsonâs Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study (Neurology and Therapy, (2023), 12, 6, (1937-1958), 10.1007/s40120-023-00533-1)
\ua9 2023, The Author(s).In the sentences beginning âAt baseline,âŠâ and âThe reduction of early morningâŠâ in the section âEfficacyâ under the heading âResultsâ in this article, the n/N values â129/238, 20/139, 25/125 and 56/125â were incorrect and the correct sentences should have read as follows: At baseline, 77.7% (n/N = 129/166) of patients experienced morning akinesia, which decreased to 19.2% (n/N = 20/104) at week 26, and 27.8% (n/N = 25/90) at week 52. The reduction of early morning âOffâ time was accompanied by a marked increase in the proportion of patients reporting âOnâ time without dyskinesia on awakening (62.2%; n/N = 56/90 at week 52) (Fig. 3). In the sentence beginning âThe reduction of âOffâ time is particularly exemplified byâŠâ under the heading âDiscussionâ, the value â(changed from 17.5% at baseline to 63.0% at week 52)â should have read â(changed from 17.5% at baseline to 62.2% at week 52).â The original article has been corrected