Objective: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.Method: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.Results: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], p = .793). Consistent improvement in CGI-I was observed. The incidence of treatment-emergent adverse events was similar for each treatment sequence.Conclusions:PRC-063 and LDX had comparable effects on driving performance, from 1 through 15 hours, the last time point measured.

中文翻译：

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多层缓释哌甲酯 (PRC-063) 和赖右苯丙胺对 ADHD 年轻人驾驶表现的随机、3 期、双盲、交叉比较

目的：在一项随机、双盲、交叉研究中比较 PRC-063（多层释放哌醋甲酯）和二甲磺酸赖右安非他明 (LDX) 对患有注意缺陷多动障碍 (ADHD) 的年轻人的驾驶表现。每个治疗疗程（PRC-063/LDX或LDX/PRC-063）的每次治疗21天，受试者完成了15小时的驾驶模拟器实验室评估。主要结果指标是战术驾驶商数 (TDQ)，次要结果指标是临床总体印象改善量表 (CGI-I)。 结果：44 名受试者完成了研究。PRC-063 和 LDX 在 15 小时内对驾驶表现具有相同的影响（最小二乘均差 −0.3 [标准误差 1.08]，95% 置信区间 [−2.4, 1.8]，p = .793）。观察到 CGI-I 的持续改善。每种治疗顺序的治疗中出现的不良事件的发生率相似。结论：PRC-063 和 LDX 对驾驶性能的影响相当，从 1 小时到 15 小时（最后测量的时间点）。