Category: Parkinson’s Disease: Clinical Trials
Objective: To describe the long-term experience of three individual patients receiving subcutaneous (SC) levodopa/carbidopa infusion with ND0612 in an open-label clinical safety study.
Background: ND0612 is in development as a continuous SC levodopa/carbidopa delivery system for patients with Parkinson’s disease (PD) experiencing motor fluctuations. Primary data from the BeyoND study showed that ND0612 is generally safe up to 1 year of treatment [1].
Method: We report three individual cases (1M/2F) from the USA (2 sites) and Israel (1 site). Eligible patients (aged ≥30 years) had a diagnosis of PD (Hoehn & Yahr Stage ≤3) and were experiencing ≥2 hours of OFF time/day despite receiving ≥4 levodopa doses/day and ≥1 other PD medication
Results: All three cases received continuous ND0612 for 24-hours/day. These patients were aged 63-68 years old, BMI 22.8-32.5, Hoehn and Yahr Stage 2-3, and experiencing motor fluctuations for 2-7 years. All three patients showed relevant reductions from baseline in OFF time and increases in ON time without troublesome dyskinesia, which were maintained until last date of efficacy follow-up. All three patients experienced infusion site reactions starting early after treatment initiation. Nodules and bruising were mild to moderate and well tolerated. One case had a serious infusion site infection which was managed successfully with antibiotics and abscess drainage. This patient decided to continue ND0612 treatment because of its favorable effect on motor fluctuations and gait.
Conclusion: Continuing into their fifth year of treatment, these patients exemplify the favorable long-term benefit/risk profile of ND0612 and will serve to inform future patient selection and education.
References: [1] Poewe W, Stocchi F, Arkadir D, et al. Subcutaneous Levodopa Infusion for Parkinson’s disease: One-Year Data from the Open-Label BeyoND study. Mov Disord 36(11):2687-2692.
To cite this abstract in AMA style:
A. Espay, A. Ellenbogen, T. Gurevich, R. Case, L. Adar, T. Yardeni, L. Salin. Descriptive case studies of patients in their fifth consecutive year of treatment with ND0612 [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/descriptive-case-studies-of-patients-in-their-fifth-consecutive-year-of-treatment-with-nd0612/. Accessed June 15, 2025.« Back to 2022 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/descriptive-case-studies-of-patients-in-their-fifth-consecutive-year-of-treatment-with-nd0612/