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Subcutaneous Levodopa Infusion for Parkinson's Disease: 1-Year Data from the Open-Label BeyoND Study
Werner Poewe1, Fabrizio Stocchi2, David Arkadir3
1Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.
Movement Disorders : Official Journal of the Movement Disorder Society
|September 8, 2021
Summary
Continuous subcutaneous levodopa/carbidopa infusion (ND0612) is safe for Parkinson's disease patients. Most adverse events were mild infusion site reactions, with few leading to discontinuation.
Area of Science:
- Neurology
- Pharmacology
- Biomedical Engineering
Background:
- Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor fluctuations.
- Continuous, subcutaneous (SC) levodopa/carbidopa infusion (ND0612) is being developed to manage these fluctuations.
Purpose of the Study:
- To evaluate the 1-year safety and tolerability of ND0612 in patients with Parkinson's disease.
Main Methods:
- The BeyoND study is an open-label trial assessing two ND0612 dosing regimens.
- 214 patients were enrolled: 90 received 24-hour SC infusion, and 124 received 16-hour SC infusion.
Main Results:
- 120 patients (56%) completed 12 months of treatment; discontinuation rates decreased post-protocol revision.
- Systemic safety was consistent with existing levodopa/carbidopa treatments.
- Infusion site reactions, including nodules (30.8%) and hematoma (25.2%), were common but mostly mild-to-moderate, leading to discontinuation in 10.3% of participants.
Conclusions:
- Continuous SC levodopa/carbidopa infusion with ND0612 demonstrates a generally safe profile for Parkinson's disease management.
- Infusion site reactions are the primary adverse events associated with SC delivery, typical for this administration route.
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