Category: Parkinson’s Disease: Clinical Trials
Objective: To review quality of life and other patient reported outcomes data from the ND0612 BeyoND study.
Background: ND0612 is in development as a continuous, subcutaneous levodopa/carbidopa (LD/CD) delivery system for PD patients experiencing motor fluctuations. Primary safety data show that subcutaneous levodopa/carbidopa infusion with ND0612 is generally safe and well tolerated for ≥1 year of treatment .
Method: The BeyoND study is an ongoing international, open-label Phase 2b study (NCT02726386) evaluating the long-term safety of continuous, subcutaneous levodopa/carbidopa infusion with ND0612 in PD patients with Hoehn & Yahr score of ≤3 during ON and experiencing ≥2 hours daily OFF-time. Exploratory evaluations of efficacy included patient quality of life as assessed by Parkinson’s Disease Questionnaire-39 (PDQ-39) and European Quality of Life 5 Dimensions 5 Level Questionnaire (EQ-5D-5L). In addition, patients rated their own clinical status using the Subject Global impression of Improvement (SGI-I). Patient reported outcomes are presented here for 1-year completers (16h and 24h regimens combined).
Results: Overall, 120 of the 214 enrolled patients completed the first year of treatment. At one year, quality of life as assessed by PDQ-39 summary index changed (improved) by -5.8 points vs baseline with the most substantial improvements in the domains of mobility (-9.0), bodily discomfort (-8.4), stigma (-7.9) and activities of daily living (-6.5). A similar pattern of improvement was seen on the EQ-5D-5L Visual Analogue Scale (VAS) score which improved by 8.4 points vs baseline. A high proportion of patients reported improvement on SGI-I over the first year of treatment, with 74.7% reporting improvement at Month 12.
Conclusion: This open-label study provides preliminary support for the 12-month efficacy of treatment with ND0612 in improving quality of life and global clinical status in patients with PD experiencing motor fluctuations.
References:  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 36(11):2687-2692.
To cite this abstract in AMA style:W. Poewe, F. Stocchi, L. Adar, T. Yardeni, A. Espay. Quality of life and patient reported outcomes with subcutaneous levodopa/carbidopa infusion: Findings from the ND0612 BeyoND study [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/quality-of-life-and-patient-reported-outcomes-with-subcutaneous-levodopa-carbidopa-infusion-findings-from-the-nd0612-beyond-study/. Accessed September 21, 2023.
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MDS Abstracts - https://www.mdsabstracts.org/abstract/quality-of-life-and-patient-reported-outcomes-with-subcutaneous-levodopa-carbidopa-infusion-findings-from-the-nd0612-beyond-study/