Hauser R A, Fernandez H H, Jimenez-Shahed J, Allard S, Banisadr G, Fisher S, D'Souza R
University of South Florida, Tampa, FL, USA.
Center for Neurological Restoration, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Parkinsonism Relat Disord. 2025 Feb;131:107239. doi: 10.1016/j.parkreldis.2024.107239. Epub 2024 Dec 15.
For Parkinson's disease patients with motor fluctuations, the duration of benefit per levodopa dose is a key metric that reflects a patient's clinical response.
Determine the difference in mean durations of "Good On" time per dose of subjects randomized to extended-release carbidopa-levodopa (ER CD-LD; IPX203; CREXONT®) vs. immediate-release (IR) CD-LD in the RISE-PD trial.
"Good On" time per dose was assessed at the end of the IR CD-LD dose adjustment phase (Visit 2/Week 3) and compared to End of Study (Visit 7/EOS) between IPX203 and IR CD-LD groups. In addition, to understand if "Good On" time per dose for IR CD-LD before conversion to IPX203 could impact the magnitude of change in "Good On" time per dose of IPX203 vs. IR CD-LD after conversion, subjects were rank-ordered and divided into quartiles based on their initial "Good On" time per dose optimized IR CD-LD values. Changes in "Good On" time per dose between IPX203 and IR CD-LD groups were then compared for each quartile from Visit 2 to EOS.
IPX203 increased "Good On" time per dose compared to IR CD-LD by a mean of 1.6 h (p < 0.0001). The mean differences in "Good On" time per dose between IPX203 and IR CD-LD were 1.53h for quartile one, 1.39h for quartile two, 1.83h for quartile three, and 1.56h for quartile four (p < 0.0001 for all quartiles).
IPX203 significantly increased "Good On" time per dose regardless of the duration of "Good On" time per dose observed with IR CD-LD.
对于有运动波动的帕金森病患者，每剂左旋多巴的获益时长是反映患者临床反应的关键指标。
在RISE-PD试验中，确定随机接受缓释卡比多巴-左旋多巴（ER CD-LD；IPX203；CREXONT®）与速释（IR）CD-LD治疗的受试者每剂“开期良好”时间的平均时长差异。
在IR CD-LD剂量调整阶段结束时（访视2/第3周）评估每剂“开期良好”时间，并在IPX203组和IR CD-LD组之间与研究结束时（访视7/研究结束）进行比较。此外，为了解转换为IPX203之前IR CD-LD的每剂“开期良好”时间是否会影响转换后IPX203与IR CD-LD每剂“开期良好”时间的变化幅度，根据受试者初始每剂“开期良好”时间优化后的IR CD-LD值进行排序并分为四分位数。然后比较从访视2到研究结束时每组四分位数中IPX203组和IR CD-LD组每剂“开期良好”时间的变化。
与IR CD-LD相比，IPX203使每剂“开期良好”时间平均增加1.6小时（p < 0.0001）。IPX203与IR CD-LD每剂“开期良好”时间的平均差异在第一四分位数为1.53小时，第二四分位数为1.39小时，第三四分位数为1.83小时，第四四分位数为1.56小时（所有四分位数p < 0.0001）。
无论IR CD-LD观察到的每剂“开期良好”时间长短如何，IPX203均显著增加了每剂“开期良好”时间。
