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

and for the BeyoND study group

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)2687-2692
Number of pages6
JournalMovement Disorders
Volume36
Issue number11
DOIs
StatePublished - Nov 2021

Keywords

  • infusion
  • levodopa
  • ND0612
  • Parkinson's disease
  • safety
  • subcutaneous

Fingerprint

Dive into the research topics of 'Subcutaneous Levodopa Infusion for Parkinson's Disease: 1-Year Data from the Open-Label BeyoND Study'. Together they form a unique fingerprint.

Cite this