Category: Parkinson’s Disease: Clinical Trials
Objective: The primary objective of this long-term study was to evaluate the safety and tolerability of a 24-hour regimen and a 16-hour ‘waking day’ regimen of ND0612.
Background: ND0612 is in development as the first drug-device combination delivering liquid levodopa/carbidopa via continuous subcutaneous (SC) infusion to reduce motor fluctuations in patients with PD.
Method: This open-label safety study (NCT02726386) was conducted in PD patients (aged >30 years, Hoehn & Yahr Stage ≤3 during ON) taking ≥4 levodopa doses/day and ≥1 other PD medication and experiencing ≥2 hours of OFF time/day with predictable early-morning OFF periods. Patients were assigned to receive ND0612 for a regimen of either 16-hours/day or 24-hours/day. Safety and tolerability were assessed through treatment-emergent adverse event (TEAE) reporting.
Results: 214 patients were enrolled (24-hour regimen: n=90; 16-hour regimen: n=124) at 46 sites in 8 countries. Overall, 66.4% of patients were male and the mean ±SD age was 64.0 ±8.9 years. Over the course of the one-year treatment period, 86% of patients had ≥1 TEAE, 66% experienced treatment-related TEAE’s and 5.6% experienced serious treatment-related TEAE’s. Systemic safety is typical for PD patients treated with levodopa/carbidopa. The most frequent AEs were typical for a continuous subcutaneous mode of drug administration and included infusion-site nodules (30.8%), infusion-site hematoma (25.2%), and infusion-site pain (13.1%). Overall, 17.8% patients discontinued due to AEs.
Conclusion: ND0612 infusion was found to be safe with generally mild to moderate local AEs which were reversible and manageable and no unexpected TEAEs for systemic levodopa treatment. Long-term data will continue to be collected in patients enrolled in the study extension, some of whom are now in their fourth year of ND0612 treatment.
Partial data presented at EAN 2020 and AAN 2020.
To cite this abstract in AMA style:
S. Isaacson, W. Poewe, T. Simuni, O. Rosenfeld, R. Case, T. Yardeni, W. Olanow. Long term safety of levodopa/carbidopa infusion with ND0612: Results from a phase 2b, international, open-label study [abstract]. Mov Disord. 2020; 35 (suppl 1). https://www.mdsabstracts.org/abstract/long-term-safety-of-levodopa-carbidopa-infusion-with-nd0612-results-from-a-phase-2b-international-open-label-study/. Accessed June 15, 2025.« Back to MDS Virtual Congress 2020
MDS Abstracts - https://www.mdsabstracts.org/abstract/long-term-safety-of-levodopa-carbidopa-infusion-with-nd0612-results-from-a-phase-2b-international-open-label-study/