Category: Parkinson’s Disease: Clinical Trials
Objective: Evaluate quality of life (QoL) data from the Phase 3 randomized, active-controlled BouNDless study.
Background: Pivotal data from the BouNDless study (NCT04006210) showed that treatment with investigational ND0612 provided patients with Parkinson’s disease (PD) and motor fluctuations an additional 1.72h [95%CI: 1.08h, 2.36h] of ON-time without troublesome dyskinesia compared with IR-LD/CD (p<0.0001).
Method: Patients with PD on ≥4 oral LD/CD doses/day (≥400mg/day LD) and experiencing ≥2.5h of daily OFF-time underwent 4-6 weeks of open-label IR-LD/CD dose adjustment followed by 4-6 weeks of open-label ND0612 conversion (+ IR-LD/CD). Patients were then randomized (1:1) to 12-week double-blind treatment with either their optimized regimen of ND0612 or IR-LD/CD. Change from the start of open-label ND0612 conversion to end of double-blind treatment in QoL was assessed using the PD Questionaire-39 (PDQ-39) and analyzed using ANCOVA following multiple imputation.
Results: At the end of the double-blind phase, the adjusted mean [95% CI] change in PDQ-39 index scores showed improvements with ND0612 treatment (-2.1 [-3.7, -0.6]) compared to no change in the IR-LD/CD group (+0.6 [-0.9, 2.1]), resulting in a treatment difference of -2.7 [-4.8, -0.6] (nominal p=0.014). PDQ-39 domain analyses favored ND0612 treatment in most domains; mean changes (ND0612 vs IR-LD/CD) were: mobility (-0.2 vs +2.4), bodily discomfort (-4.3 vs -2.3), cognition (-0.9 vs -0.3), activities of daily living (-0.6 vs -0.1), stigma (-2.6 vs -2.4), social support (0.4 vs 0.7), communication (2.3 vs -0.4), and emotional well-being (0.6 vs -1.3).
Conclusion: ND0612 improved quality-of-life as measured by PDQ-39 compared to IR-LD/CD, further supporting the clinical meaningfulness of the observed reduction in motor fluctuations from a PD patient perspective.
To cite this abstract in AMA style:
H. Sarva, M. Tagliati, W. Poewe, F. Stocchi, O. Rascol, T. Yardeni, N. Lopes, J. Pereira, A. Espay. Quality of Life with 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612): PDQ-39 Results from a Phase 3 Randomized Active-Controlled Study [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/quality-of-life-with-24-hour-subcutaneous-levodopa-carbidopa-infusion-nd0612-pdq-39-results-from-a-phase-3-randomized-active-controlled-study/. Accessed June 14, 2025.« Back to 2024 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/quality-of-life-with-24-hour-subcutaneous-levodopa-carbidopa-infusion-nd0612-pdq-39-results-from-a-phase-3-randomized-active-controlled-study/