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Subcutaneous Levodopa Infusion for Parkinson's Disease: 1 ‐Year Data from the Open‐Label BeyoND Study
Author(s) -
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.
Publication year - 2021
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.28758
Subject(s) - parkinson's disease , open label , levodopa , medicine , disease , clinical trial
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