Sökning: onr:"swepub:oai:gup.ub.gu.se/331488" > Continuous Subcutan...
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000 | 04591naa a2200577 4500 | |
001 | oai:gup.ub.gu.se/331488 | |
003 | SwePub | |
008 | 240528s2023 | |||||||||||000 ||eng| | |
024 | 7 | a https://gup.ub.gu.se/publication/3314882 URI |
024 | 7 | a https://doi.org/10.1007/s40120-023-00533-12 DOI |
040 | a (SwePub)gu | |
041 | a eng | |
042 | 9 SwePub | |
072 | 7 | a ref2 swepub-contenttype |
072 | 7 | a art2 swepub-publicationtype |
100 | 1 | a Aldred, Jason4 aut |
245 | 1 0 | a Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study. |
264 | 1 | c 2023 |
520 | a Foslevodopa/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.Male and female patients with levodopa-responsive PD and≥2.5hours of "Off" time/day received 24-hour/day foslevodopa/foscarbidopa CSCI at individually optimized therapeutic doses (approximately 700-4250mg of LD per 24hours) for 52weeks. 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).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, "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.Foslevodopa/foscarbidopa has the potential to provide a safe and efficacious, individualized, 24-hour/day, nonsurgical alternative for patients with PD.ClinicalTrials.gov identifier NCT03781167. | |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Neurologi0 (SwePub)302072 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Neurology0 (SwePub)302072 hsv//eng |
653 | a Advanced Parkinson’s disease | |
653 | a Foslevodopa/foscarbidopa | |
653 | a Levodopa/carbidopa prodrugs | |
653 | a Motor fluctuations | |
653 | a Subcutaneous infusion | |
700 | 1 | a Freire-Alvarez, Eric4 aut |
700 | 1 | a Amelin, Alexander V4 aut |
700 | 1 | a Antonini, Angelo4 aut |
700 | 1 | a Bergmans, Bruno4 aut |
700 | 1 | a Bergquist, Filip,d 1970u Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för farmakologi,Institute of Neuroscience and Physiology, Department of Pharmacology4 aut0 (Swepub:gu)xberfi |
700 | 1 | a Bouchard, Manon4 aut |
700 | 1 | a Budur, Kumar4 aut |
700 | 1 | a Carroll, Camille4 aut |
700 | 1 | a Chaudhuri, K Ray4 aut |
700 | 1 | a Criswell, Susan R4 aut |
700 | 1 | a Danielsen, Erik H4 aut |
700 | 1 | a Gandor, Florin4 aut |
700 | 1 | a Jia, Jia4 aut |
700 | 1 | a Kimber, Thomas E4 aut |
700 | 1 | a Mochizuki, Hideki4 aut |
700 | 1 | a Robieson, Weining Z4 aut |
700 | 1 | a Spiegel, Amy M4 aut |
700 | 1 | a Standaert, David G4 aut |
700 | 1 | a Talapala, Saritha4 aut |
700 | 1 | a Facheris, Maurizio F4 aut |
700 | 1 | a Fung, Victor S C4 aut |
710 | 2 | a Göteborgs universitetb Institutionen för neurovetenskap och fysiologi, sektionen för farmakologi4 org |
773 | 0 | t Neurology and Therapyg 12:6, s. 1937-1958q 12:6<1937-1958x 2193-8253x 2193-6536 |
856 | 4 8 | u https://gup.ub.gu.se/publication/331488 |
856 | 4 8 | u https://doi.org/10.1007/s40120-023-00533-1 |
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