Objective:

To evaluate the efficacy, safety, and duration of action of the once-daily extended-release methylphenidate formulation PRC-063 for the treatment of ADHD in an adult laboratory classroom (ALC).

Method:

After dose optimization with PRC-063 over 7 weeks, adults with ADHD were randomized to 1 week of double-blind treatment with PRC-063 or placebo that ended with an ALC evaluation. The primary outcome measure was Permanent Product Measure of Performance-Total (PERMP-T) score.

Results:

Of 288 subjects enrolled, 221 completed the ALC visit. PERMP-T score was significantly higher for PRC-063 versus placebo at every assessment from 1 to 16 hours post-dose at the ALC visit and when averaged over 16 hours post-dose (least-squares mean difference 16.3, 95% confidence interval 7.6–24.9). The most frequent adverse events during dose optimization were headache, decreased appetite, and insomnia.

Conclusion:

PRC-063 provided rapid and sustained symptom relief in adults with ADHD and was well tolerated. NCT03618030.

中文翻译：

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随机、双盲、安慰剂对照、平行组、成人实验室课堂研究 PRC-063（延长释放哌醋甲酯）治疗 ADHD 的疗效和安全性

客观的：

评估每日一次的哌醋甲酯缓释制剂 PRC-063 在成人实验室教室 (ALC) 中治疗 ADHD 的疗效、安全性和作用持续时间。

方法：

在 7 周内使用 PRC-063 优化剂量后，患有 ADHD 的成年人被随机分配到使用 PRC-063 或安慰剂的 1 周双盲治疗，最后以 ALC 评估结束。主要结果测量是绩效总成绩的永久产品测量 (PERMP-T) 评分。

结果：

在登记的 288 名受试者中，221 名完成了 ALC 访问。与安慰剂相比，PRC-063 的 PERMP-T 评分显着高于安慰剂，在 ALC 就诊时给药后 1 至 16 小时以及给药后 16 小时内平均时（最小二乘均数差 16.3，95% 置信区间 7.6 –24.9)。剂量优化期间最常见的不良事件是头痛、食欲下降和失眠。

结论：

PRC-063 为患有 ADHD 的成年人提供了快速和持续的症状缓解，并且耐受性良好。NCT03618030。