Objective: Evaluate the effect of investigational ND0612 on motor signs of PD and motor experiences of daily living (m-EDL), as assessed using the MDS-UPDRS.

Background: We have previously reported that the BouNDless study [1] demonstrated superiority of ND0612 over immediate-release levodopa/carbidopa (IR-LD/CD) in reducing motor fluctuations and improving m-EDL (MDS-UPDRS Part II).

Method: MDS-UPDRS Part II and Part III (at OFF-state) subscores were assessed in the BouNDless study (NCT04006210) at ND0612 initiation (ie, in the run-in phase) and at double-blind period Weeks 8 and 12. Here we present descriptive analyses of changes from ND0612 initiation to each double-blind visit. Additionally, a post hoc analysis was performed with grouped symptom-related items (from Parts II and III) for 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: Treatment differences (ND0612 vs IR-LD/CD) in Part II subscores favoring ND0612 over IR-LD/CD were observed at both Week 8 (mean [95% CI] difference: –2.4 [–3.5, –1.3]) and Week 12 (–3.1 [–4.3, –1.8]). Similarly, treatment differences in Part III subscores were –4.2 [–6.7, –1.7] at Week 8 and –2.4 [–5.2, 0.4] at Week 12. Differences favoring ND0612 vs IR-LD/CD were observed for 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.

Conclusion: In addition to reducing motor fluctuations, our results support the clinical benefit of ND0612 24-hour continuous subcutaneous therapy across different symptom domains of MDS-UPDRS II and III.

References: [1] Espay et al. Safety and efficacy of continuous subcutaneous levodopa–carbidopa infusion (ND0612) for Parkinson’s disease with motor fluctuations (BouNDless): a phase 3, randomised, double-blind, double-dummy, multicentre trial. Lancet Neurol; 2024. In press.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-of-continuous-subcutaneous-levodopa-carbidopa-infusion-nd0612-on-motor-signs-of-pd-and-experiences-of-daily-living/