Dataset Information
Subcutaneous Levodopa Infusion for Parkinson's Disease: 1-Year Data from the Open-Label BeyoND Study.
Ontology highlight
ABSTRACT: 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.
SUBMITTER: Poewe W
PROVIDER: S-EPMC9291977 | biostudies-literature | 2021 Nov
REPOSITORIES: biostudies-literature
Publications
Subcutaneous Levodopa Infusion for Parkinson's Disease: 1-Year Data from the Open-Label BeyoND Study.
Movement disorders : official journal of the Movement Disorder Society 20210908 11
<h4>Background</h4>Continuous, subcutaneous (SC) levodopa/carbidopa infusion with ND0612 is under development as a treatment for patients with Parkinson's disease (PD) and motor fluctuations.<h4>Objective</h4>Evaluate 1-year safety data.<h4>Methods</h4>BeyoND is an open-label study evaluating the long-term safety of two ND0612 dosing regimens.<h4>Results</h4>Of the 214 enrolled patients (24-hour SC infusion: n = 90; 16-hour SC infusion: n = 124), 120 (56%) completed 12 months of treatment. Leadi ...[more]