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

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 infus

SUBMITTER: Poewe W 

PROVIDER: S-EPMC9291977 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature