Sökning: onr:"swepub:oai:gup.ub.gu.se/331488" >
Continuous Subcutan...
-
Aldred, Jason
(författare)
Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study.
- Artikel/kapitelEngelska2023
Förlag, utgivningsår, omfång ...
Nummerbeteckningar
-
LIBRIS-ID:oai:gup.ub.gu.se/331488
-
https://gup.ub.gu.se/publication/331488URI
-
https://doi.org/10.1007/s40120-023-00533-1DOI
Kompletterande språkuppgifter
Ingår i deldatabas
Klassifikation
-
Ämneskategori:ref swepub-contenttype
-
Ämneskategori:art swepub-publicationtype
Anmärkningar
-
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.
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
-
Freire-Alvarez, Eric
(författare)
-
Amelin, Alexander V
(författare)
-
Antonini, Angelo
(författare)
-
Bergmans, Bruno
(författare)
-
Bergquist, Filip,1970Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för farmakologi,Institute of Neuroscience and Physiology, Department of Pharmacology(Swepub:gu)xberfi
(författare)
-
Bouchard, Manon
(författare)
-
Budur, Kumar
(författare)
-
Carroll, Camille
(författare)
-
Chaudhuri, K Ray
(författare)
-
Criswell, Susan R
(författare)
-
Danielsen, Erik H
(författare)
-
Gandor, Florin
(författare)
-
Jia, Jia
(författare)
-
Kimber, Thomas E
(författare)
-
Mochizuki, Hideki
(författare)
-
Robieson, Weining Z
(författare)
-
Spiegel, Amy M
(författare)
-
Standaert, David G
(författare)
-
Talapala, Saritha
(författare)
-
Facheris, Maurizio F
(författare)
-
Fung, Victor S C
(författare)
-
Göteborgs universitetInstitutionen för neurovetenskap och fysiologi, sektionen för farmakologi
(creator_code:org_t)
Sammanhörande titlar
-
Ingår i:Neurology and Therapy12:6, s. 1937-19582193-82532193-6536
Internetlänk
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Aldred, Jason
-
Freire-Alvarez, ...
-
Amelin, Alexande ...
-
Antonini, Angelo
-
Bergmans, Bruno
-
Bergquist, Filip ...
-
visa fler...
-
Bouchard, Manon
-
Budur, Kumar
-
Carroll, Camille
-
Chaudhuri, K Ray
-
Criswell, Susan ...
-
Danielsen, Erik ...
-
Gandor, Florin
-
Jia, Jia
-
Kimber, Thomas E
-
Mochizuki, Hidek ...
-
Robieson, Weinin ...
-
Spiegel, Amy M
-
Standaert, David ...
-
Talapala, Sarith ...
-
Facheris, Mauriz ...
-
Fung, Victor S C
-
visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Neurologi
- Artiklar i publikationen
-
Neurology and Th ...
- Av lärosätet
-
Göteborgs universitet