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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00004591naa a2200577 4500
001oai:gup.ub.gu.se/331488
003SwePub
008240528s2023 | |||||||||||000 ||eng|
0247 a https://gup.ub.gu.se/publication/3314882 URI
0247 a https://doi.org/10.1007/s40120-023-00533-12 DOI
040 a (SwePub)gu
041 a eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Aldred, Jason4 aut
2451 0a Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study.
264 1c 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 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Neurologi0 (SwePub)302072 hsv//swe
650 7a 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
7001 a Freire-Alvarez, Eric4 aut
7001 a Amelin, Alexander V4 aut
7001 a Antonini, Angelo4 aut
7001 a Bergmans, Bruno4 aut
7001 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
7001 a Bouchard, Manon4 aut
7001 a Budur, Kumar4 aut
7001 a Carroll, Camille4 aut
7001 a Chaudhuri, K Ray4 aut
7001 a Criswell, Susan R4 aut
7001 a Danielsen, Erik H4 aut
7001 a Gandor, Florin4 aut
7001 a Jia, Jia4 aut
7001 a Kimber, Thomas E4 aut
7001 a Mochizuki, Hideki4 aut
7001 a Robieson, Weining Z4 aut
7001 a Spiegel, Amy M4 aut
7001 a Standaert, David G4 aut
7001 a Talapala, Saritha4 aut
7001 a Facheris, Maurizio F4 aut
7001 a Fung, Victor S C4 aut
7102 a Göteborgs universitetb Institutionen för neurovetenskap och fysiologi, sektionen för farmakologi4 org
7730 t Neurology and Therapyg 12:6, s. 1937-1958q 12:6<1937-1958x 2193-8253x 2193-6536
8564 8u https://gup.ub.gu.se/publication/331488
8564 8u https://doi.org/10.1007/s40120-023-00533-1

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