Subcutaneous Levodopa Infusion for Parkinson's Disease: 1<scp>‐Year</scp> Data from the <scp>Open‐Label BeyoND</scp> Study
Werner Poewe, Fabrizio Stocchi, David Arkadir, Georg Ebersbach, Aaron Ellenbogen, Nir Giladi, Stuart Isaacson, Karl Kieburtz, Peter A. LeWitt, C. Warren Olanow, Tanya Simuni, Astrid Thomas, Abraham Zlotogorski, Liat Adar, Ryan Case, Sheila Oren, Shir Fuchs Orenbach, Olivia Rosenfeld, Nissim Sasson, Tami Yardeni, Alberto J. Espay, and for the BeyoND study group
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.