Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA.
SUNY Upstate Medical University and Neuroscience Education Institute, Lakewood Ranch, FL, USA.
J Atten Disord. 2022 Apr;26(6):857-869. doi: 10.1177/10870547211025610. Epub 2021 Jun 30.
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).
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.
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.
PRC-063 provided rapid and sustained symptom relief in adults with ADHD and was well tolerated. NCT03618030.
评估每日一次的哌甲酯缓释制剂 PRC-063 治疗成人实验室课堂（ALC）中 ADHD 的疗效、安全性和作用持续时间。
在经过 7 周的 PRC-063 剂量优化后，ADHD 成人患者被随机分配接受 1 周的 PRC-063 或安慰剂双盲治疗，治疗结束时进行 ALC 评估。主要结局测量指标为 PERMP-T 总分。
在 288 名入组患者中，有 221 名完成了 ALC 就诊。在 ALC 就诊时，PRC-063 与安慰剂相比，在 1 至 16 小时的每个时间点，以及在 16 小时后平均的 PERMP-T 评分均显著更高（最小二乘均值差异 16.3，95%置信区间 7.6-24.9）。在剂量优化期间最常见的不良反应是头痛、食欲下降和失眠。
PRC-063 为 ADHD 成人患者提供了快速和持续的症状缓解，且耐受性良好。NCT03618030。
