Document detail
ID
oai:pubmedcentral.nih.gov:9291...
Topic
Regular Issue ArticlesAuthor
Poewe, Werner Stocchi, Fabrizio Arkadir, David Ebersbach, Georg Ellenbogen, Aaron L. Giladi, Nir Isaacson, Stuart H. Kieburtz, Karl LeWitt, Peter Olanow, C. Warren Simuni, Tanya Thomas, Astrid Zlotogorski, Abraham Adar, Liat Case, Ryan Oren, Sheila Fuchs Orenbach, Shir Rosenfeld, Olivia Sasson, Nissim Yardeni, Tami Espay, Alberto J.Langue
enEditor
John Wiley & Sons, Inc.
Category
Wiley-Blackwell Online Open
Year
2021
listing date
12/1/2023
Keywords
levodopa/carbidopa study discontinuation safety nd0612 subcutaneous parkinsonAbstract
BACKGROUND: Continuous, subcutaneous (SC) levodopa/carbidopa infusion with ND0612 is under development as a treatment for patients with Parkinson's disease (PD) and motor fluctuations.
OBJECTIVE: Evaluate 1‐year safety data.
METHODS: BeyoND is an open‐label study evaluating the long‐term safety of two ND0612 dosing regimens.
RESULTS: Of the 214 enrolled patients (24‐hour SC infusion: n = 90; 16‐hour SC infusion: n = 124), 120 (56%) completed 12 months of treatment.
Leading causes for study discontinuation were consent withdrawal (19.6%) and adverse events (17.3%).
Rates of discontinuation were reduced from 49% to 29% after a protocol revision and retraining.
Systemic safety was typical for PD patients treated with levodopa/carbidopa.
Most patients experienced infusion site reactions, particularly nodules (30.8%) and hematoma (25.2%), which were judged mostly mild to moderate and led to discontinuation in only 10.3% of the participants.
CONCLUSIONS: Subcutaneous levodopa/carbidopa continuous infusion with ND0612 is generally safe, with typical infusion site reactions for SC delivery as the main adverse event.
© 2021 The Authors.
Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society
Poewe, Werner,Stocchi, Fabrizio,Arkadir, David,Ebersbach, Georg,Ellenbogen, Aaron L.,Giladi, Nir,Isaacson, Stuart H.,Kieburtz, Karl,LeWitt, Peter,Olanow, C. Warren,Simuni, Tanya,Thomas, Astrid,Zlotogorski, Abraham,Adar, Liat,Case, Ryan,Oren, Sheila,Fuchs Orenbach, Shir,Rosenfeld, Olivia,Sasson, Nissim,Yardeni, Tami,Espay, Alberto J.,, 2021, Subcutaneous Levodopa Infusion for Parkinson's Disease: 1‐Year Data from the Open‐Label BeyoND Study, John Wiley & Sons, Inc.
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