American Psychiatric Association, Washington, DC, USA.
Imbrium Therapeutics L.P., A Subsidiary of Purdue Pharma L.P., Stamford, CT, USA.
J Atten Disord. 2024 Apr;28(6):947-956. doi: 10.1177/10870547241226634. Epub 2024 Feb 25.
To compare PRC-063 (multilayer-release methylphenidate) and lisdexamfetamine dimesylate (LDX) on the driving performance of young adults with attention deficit hyperactivity disorder (ADHD) in a randomized, double-blind, crossover study.
Following up to 21 days of each treatment in each treatment course (PRC-063/LDX or LDX/PRC-063), subjects completed a 15-hour driving simulator laboratory assessment. The primary outcome measure was the Tactical Driving Quotient (TDQ) and the Clinical Global Impressions-Improvement (CGI-I) scale was a secondary outcome measure.
Forty-four subjects completed the study. PRC-063 and LDX had equivalent effects on driving performance through a 15-hour time period (least square mean difference -0.3 [standard error 1.08], 95% confidence interval [-2.4, 1.8], = .793). Consistent improvement in CGI-I was observed. The incidence of treatment-emergent adverse events was similar for each treatment sequence.
PRC-063 and LDX had comparable effects on driving performance, from 1 through 15 hours, the last time point measured.
在一项随机、双盲、交叉研究中，比较 PRC-063（多层层析哌甲酯）和右苯丙胺 dimesylate（LDX）对患有注意缺陷多动障碍（ADHD）的年轻成年人驾驶表现的影响。
在每个治疗疗程（PRC-063/LDX 或 LDX/PRC-063）中，每个治疗周期后随访 21 天，受试者完成了 15 小时驾驶模拟器实验室评估。主要结局测量指标是战术驾驶商数（TDQ），次要结局测量指标是临床总体印象改善（CGI-I）量表。
44 名受试者完成了研究。PRC-063 和 LDX 在 15 小时的时间内对驾驶表现有相同的影响（最小二乘均数差值-0.3[标准误差 1.08]，95%置信区间[-2.4,1.8]， = .793）。观察到 CGI-I 持续改善。每种治疗序列的治疗中出现的不良事件发生率相似。
PRC-063 和 LDX 在驾驶表现方面具有可比的效果，从 1 小时到 15 小时，这是测量的最后一个时间点。
