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Continuous Subcutan...
Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study.
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Aldred, Jason (author)
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Freire-Alvarez, Eric (author)
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Amelin, Alexander V (author)
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Antonini, Angelo (author)
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Bergmans, Bruno (author)
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- Bergquist, Filip, 1970 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för farmakologi,Institute of Neuroscience and Physiology, Department of Pharmacology
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Bouchard, Manon (author)
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Budur, Kumar (author)
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Carroll, Camille (author)
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Chaudhuri, K Ray (author)
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Criswell, Susan R (author)
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Danielsen, Erik H (author)
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Gandor, Florin (author)
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Jia, Jia (author)
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Kimber, Thomas E (author)
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Mochizuki, Hideki (author)
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Robieson, Weining Z (author)
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Spiegel, Amy M (author)
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Standaert, David G (author)
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Talapala, Saritha (author)
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Facheris, Maurizio F (author)
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Fung, Victor S C (author)
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(creator_code:org_t)
- 2023
- 2023
- English.
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In: Neurology and Therapy. - 2193-8253 .- 2193-6536. ; 12:6, s. 1937-1958
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
Keyword
- Advanced Parkinson’s disease
- Foslevodopa/foscarbidopa
- Levodopa/carbidopa prodrugs
- Motor fluctuations
- Subcutaneous infusion
Publication and Content Type
- ref (subject category)
- art (subject category)
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Aldred, Jason
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Freire-Alvarez, ...
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Amelin, Alexande ...
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Antonini, Angelo
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Bergmans, Bruno
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Bergquist, Filip ...
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show more...
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Bouchard, Manon
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Budur, Kumar
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Carroll, Camille
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Chaudhuri, K Ray
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Criswell, Susan ...
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Danielsen, Erik ...
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Gandor, Florin
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Jia, Jia
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Kimber, Thomas E
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Mochizuki, Hidek ...
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Robieson, Weinin ...
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Spiegel, Amy M
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Standaert, David ...
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Talapala, Sarith ...
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Facheris, Mauriz ...
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Fung, Victor S C
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Neurology
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Neurology and Th ...
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University of Gothenburg