Category: Parkinson’s Disease: Clinical Trials
Objective: Evaluate the efficacy of subcutaneous levodopa/carbidopa infusion with investigational ND0612 in reducing OFF time in people with Parkinson’s disease (PwP) experiencing motor fluctuations.
Background: We have reported that one year treatment with ND0612 infusion is generally safe and well-tolerated. Adjusted mean daily ‘Good ON’ time (sum of ON time without dyskinesia + ON time with non-troublesome dyskinesia) increased from baseline by 2.3 hours at Month 3 and was maintained for at least 12 months [1].
Method: The BeyoND study is an ongoing open-label study (NCT02726386) of ND0612 treatment conducted in PD patients (n=214) with Hoehn & Yahr score of ≤3 during ON experiencing ≥2 hours daily OFF-time. In these analyses of daily OFF time (patient home diaries), a responder was conservatively defined as a patient who achieved ≥50% reduction from baseline in adjusted mean daily OFF time.
Results: Using the last observation carried forward, 44.0% patients were classified as treatment responders, and this level of response was maintained over the 12 months of follow-up. Moreover, 63.5% of patients achieved a >25% reduction in OFF time from baseline and 26.9% of patients achieved a >75% reduction in OFF time. Additionally, in 12.8% of patients the OFF time was completely eliminated. Using only observed cases (i.e., not LOCF), the percentage of ND0612 treatment responders increased from 44.0% at Month 1 (N=150) to 53.3% at Month 6 (N=107), and 56.7% at Month 12 (N=90).
Conclusion: This open-label study provides preliminary support for the 12-month efficacy of treatment with ND0612 in reducing OFF time in PwP experiencing motor fluctuations.
References: [1] Poewe W, Stocchi F, Arkadir D, et al. Subcutaneous Levodopa Infusion for Parkinson’s disease: One-Year Data from the Open-Label BeyoND study. Mov Disord 2021; 36(11):2687-2692.
To cite this abstract in AMA style:
A. Ellenbogen, A. Espay, S. Isaacson, N. Lopes, N. Sasson, T. Yardeni, W. Poewe. Reductions in OFF time with ND0612 for patients with Parkinson’s disease experiencing motor fluctuations: Responder-analysis from an open-label Phase 2 study [abstract]. Mov Disord. 2023; 38 (suppl 1). https://www.mdsabstracts.org/abstract/reductions-in-off-time-with-nd0612-for-patients-with-parkinsons-disease-experiencing-motor-fluctuations-responder-analysis-from-an-open-label-phase-2-study/. Accessed November 22, 2024.« Back to 2023 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/reductions-in-off-time-with-nd0612-for-patients-with-parkinsons-disease-experiencing-motor-fluctuations-responder-analysis-from-an-open-label-phase-2-study/