Objective: To evaluate the efficacy and safety of a 16-hr multilayer-release methylphenidate (PRC-063) in a community-based adult ADHD population. Method: In a double-blind study, 375 participants were randomized to one of four fixed doses of PRC-063 or placebo. The primary outcome was the ADHD-Rating Scale-5 (RS). The first 50% of double-blind completers were invited to participate in a 6-month dose-optimized open-label study to assess response and safety. Results: In total, 333 participants completed the double-blind trial; 184 entered the open-label study. PRC-063 produced greater symptom reduction in ADHD-RS-5 total score from baseline compared with placebo in the double-blind study (least-square [LS] mean = -4.7 [-7.7, -1.6], p = .003). The most frequent adverse events were headache, insomnia, and decreased appetite. No significant sleep quality impact was observed (p = .123). Significant improvements in ADHD-RS-5 scores from baseline continued through the open-label study (p < .0001), coincident with dose optimization. Conclusion: PRC-063 was well tolerated and significantly improved ADHD symptomatology in adults.

中文翻译：

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PRC-063，缓释多层哌甲酯在成人 ADHD 中的疗效和安全性，包括 6 个月的开放标签扩展。

目的：评估 16 小时多层释放哌甲酯 (PRC-063) 在基于社区的成人 ADHD 人群中的有效性和安全性。方法：在一项双盲研究中，375 名参与者被随机分配到四种固定剂量的 PRC-063 或安慰剂中的一种。主要结果是 ADHD 评级量表 5 (RS)。前 50% 的双盲完成者被邀请参加为期 6 个月的剂量优化开放标签研究，以评估反应和安全性。结果：共有333名参与者完成了双盲试验；184 人进入开放标签研究。在双盲研究中，与安慰剂相比，PRC-063 使 ADHD-RS-5 总分的症状减轻幅度更大（最小二乘 [LS] 平均值 = -4.7 [-7.7, -1.6]，p = .003） . 最常见的不良事件是头痛、失眠和食欲下降。未观察到显着的睡眠质量影响（p = .123）。ADHD-RS-5 评分相对于基线的显着改善在开放标签研究中持续（p < .0001），与剂量优化一致。结论：PRC-063 耐受性良好，可显着改善成人 ADHD 症状。