Subcutaneous Levodopa Infusion for Parkinson's Disease: 1 ‐Year Data from the Open‐Label BeyoND Study

Autor: Nissim Sasson, Shir Fuchs Orenbach, Nir Giladi, Sheila Oren, David Arkadir, Tanya Simuni, Peter A. LeWitt, Abraham Zlotogorski, Alberto J. Espay, Werner Poewe, Astrid Thomas, Karl Kieburtz, Stuart Isaacson, Georg Ebersbach, Tami Yardeni, C Warren Olanow, Liat Adar, Ryan Case, Olivia Rosenfeld, Fabrizio Stocchi, Aaron Ellenbogen
Rok vydání: 2021
Předmět:
Zdroj: Movement Disorders. 36:2687-2692
ISSN: 1531-8257
0885-3185
DOI: 10.1002/mds.28758
Popis: 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.
Databáze: OpenAIRE
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