Effect of ND0612 Continuous Infusion on Motor Performance and Experiences of Daily Living in Patients With Parkinson's Disease
Recommended Citation
Rascol O, Isaacson S, LeWitt P, Poewe W, Ferreira J, Lopes N, Sopromadze S, Pereira J. Effect of ND0612 Continuous Infusion on Motor Performance and Experiences of Daily Living in Patients With Parkinson's Disease. Parkinsonism Relat Disord 2025; 134.
Document Type
Conference Proceeding
Publication Date
5-1-2025
Publication Title
Parkinsonism Relat Disord
Abstract
Background: In the phase 3, active-controlled BouNDless study (NCT04006210), investigational ND0612 (24-hour subcutaneous levodopa/carbidopa infusion) demonstrated superiority in reducing motor fluctuations and improving motor experiences of daily living (m-EDL; MDS-UPDRS Part II), compared to oral immediate-release levodopa/carbidopa (IR-LD/CD). Our aim was to use the MDS-UPDRS to evaluate the efficacy of ND0612 in improving motor signs of PD and m-EDL. Methods: In the present study, we evaluated MDS-UPDRS Part II and Part III (at OFF-state) subscores at the time of ND0612 initiation (ie, start of open-label ND0612 treatment) and at Weeks 8 and 12 of the double-blind double-dummy maintenance period. Descriptive analyses of changes from start of ND0612 treatment to each double-blind visit are presented here. Additionally, we performed a post hoc analysis with grouped symptom-related items (from Parts II and III) for several parameters, including tremor, rigidity, bradykinesia, postural instability-gait disorder (PIGD), speech and oral health, and self-care, using a Mixed Model for Repeated Measures. P values are displayed nominally with no adjustment. Results: Mean [95%CI] treatment differences (ND0612 vs IR-LD/CD) in Part II subscores were –2.4 [–3.5, –1.3] at Week 8 and –3.1 [–4.3, –1.8] at Week 12. Similarly, treatment differences in Part III subscores favored ND0612 treatment and were –4.2 [–6.7, –1.7] at Week 8 and –2.4 [–5.2, 0.4] at Week 12. Additionally, we observed differences favoring ND0612 vs IR-LD/CD for the following parameters: PIGD (–0.26 vs 0.02, p=0.0012), speech and oral health (–0.11 vs 0.05, p=0.0140), tremor (–0.15 vs –0.05, p=0.0992), and self-care (–0.08 vs 0.09, p=0.0528). No relevant differences were observed for rigidity and bradykinesia. Conclusions: In addition to reducing motor fluctuations, these results provide further evidence supporting the clinical benefit of ND0612 therapy across different symptom domains of MDS-UPDRS II and III.
Volume
134
