Category: Parkinson’s Disease: Clinical Trials
Objective: Characterize dopaminergic treatment-emergent adverse events (TEAEs) reported with 24h ND0612 treatment in clinical studies.
Background: Dopaminergic adverse events are commonly reported across the spectrum of available dopaminergic therapies for PD. ND0612 is an investigational, continuous 24h subcutaneous infusion of levodopa/carbidopa (max daily dose 720/90 mg) in development for the management of PD motor fluctuations.
Method: An integrated safety analysis of dopaminergic TEAEs reported in PD patients treated with a 24h regimen of ND0612 and supplemental immediate-release levodopa/carbidopa, from two phase 2 (NCT02577523 and NCT02726386) and one phase 3 (NCT04006210) study was conducted (cut-off date May 5, 2023). Selected dopaminergic TEAEs of interest to this population included dizziness, nausea, vomiting, dyskinesia, hallucinations (grouped term), impulse control disorders (ICDs, grouped term), orthostatic hypotension, sleep disturbances, and somnolence. The exposure-adjusted incidence rate (EAIR) was calculated as the total number of patients who experienced a TEAE divided by the total time patients were at risk for the event (person-years).
Results: A total of 419 patients (528.8 person-years, median exposure to ND0612 of 346 days [up to 6.6 years]) were included in the analysis. The most common dopaminergic TEAE (% patients; EAIR) was dyskinesia (13.1%; 0.114). Other dopaminergic TEAEs were reported in less than 5% of patients: dizziness (4.3%; 0.035), hallucinations (3.8%; 0.031), orthostatic hypotension (3.6%; 0.029), nausea (2.9%; 0.023), somnolence (1.4%; 0.011), unspecified sleep disorder (1.2%; 0.010), and ICD (1.2%; 0.010). Vomiting, nightmares, REM sleep behavior disorders were reported in ≤3 patients each (≤ 0.7%; 0.006).
Conclusion: The 24h continuous subcutaneous administration of ND0612 demonstrated overall tolerability and a low incidence of dopaminergic adverse events.
To cite this abstract in AMA style:
S. Isaacson, O. Rascol, H. Sarva, R. Hauser, F. Stocchi, N. Lopes, L. Salin, J. Pereira, N. Giladi. Dopaminergic Adverse Events With 24-hour Subcutaneous Infusion of ND0612 [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/dopaminergic-adverse-events-with-24-hour-subcutaneous-infusion-of-nd0612/. Accessed May 19, 2025.« Back to 2024 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/dopaminergic-adverse-events-with-24-hour-subcutaneous-infusion-of-nd0612/