NWP06是一种哌甲酯缓释口服混悬液，在一项实验室课堂研究中，与安慰剂相比，它改善了注意力缺陷多动障碍症状。
NWP06, an extended-release oral suspension of methylphenidate, improved attention-deficit/hyperactivity disorder symptoms compared with placebo in a laboratory classroom study.
作者信息
Wigal Sharon B, Childress Ann C, Belden Heidi W, Berry Sally A
机构信息
Department of Pediatrics, University of California, Irvine, Irvine, CA, USA.
出版信息
J Child Adolesc Psychopharmacol. 2013 Feb;23(1):3-10. doi: 10.1089/cap.2012.0073. Epub 2013 Jan 5.
OBJECTIVE
The purpose of this study was to determine the efficacy of NWP06, a novel extended-release (ER) liquid formulation of methylphenidate (MPH), compared with placebo in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children in a laboratory school.
METHODS
A total of 45 subjects ages 6-12 years were enrolled in this dose-optimized, randomized, double-blind, placebo-controlled, crossover laboratory school study. Following open-label dose optimization, subjects received 2 weeks of double-blind treatment (1 week of NWP06 and 1 week of placebo). The treatment sequence (NWP06/placebo or placebo/NWP06) was randomly assigned with the last day of each week-long treatment occurring on the laboratory school test day. Efficacy measures included Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Rating Scale-Combined and Permanent Product Measure of Performance (PERMP) mathematics tests measured at pre-dose and at 0.75, 2, 4, 8, 10, and 12 hours post-dose on each laboratory classroom day. Safety assessments included physical examination, screening electrocardiogram (ECG), vital signs, clinical laboratory tests, adverse event measures, and assessment of suicidality with the Columbia Suicide Severity Rating Scale.
RESULTS
NWP06 resulted in significant (p<0.0001) improvements in the SKAMP-Combined score at 4 hours post-dose (mean=7.12) as compared with placebo (mean=19.58) in the completers (n=39). Significant separation from placebo occurred at each time point tested (0.75, 2, 4, 8, 10, 12 hours), with onset of action of NWP06 at 45 minutes post-dose and duration of efficacy extending to 12 hours post-dose. Adverse events (AEs) and changes in vital signs following NWP06 treatment were generally mild and consistent with the known safety profile of MPH. The most common AEs in the open-label phase were decreased appetite (55.6%), upper abdominal pain (42.2%), affect lability (26.7%), initial insomnia (22.2%), insomnia (17.8%), and headache (17.8%).
CONCLUSIONS
NWP06 treatment effectively reduced symptoms of ADHD in children beginning at 45 minutes and continuing for 12 hours post-dose. NWP06 was well tolerated.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT00904670. http://www.clinicaltrials.gov/ct2/show/NCT00904670 .
目的
本研究旨在确定新型哌甲酯缓释液体制剂NWP06与安慰剂相比，在一所实验学校中治疗儿童注意力缺陷多动障碍（ADHD）的疗效。
方法
本剂量优化、随机、双盲、安慰剂对照、交叉实验学校研究共纳入45名6至12岁的受试者。在开放标签剂量优化后，受试者接受2周的双盲治疗（1周NWP06和1周安慰剂）。治疗顺序（NWP06/安慰剂或安慰剂/NWP06）随机分配，每周治疗的最后一天为实验学校测试日。疗效指标包括在每个实验学校上课日的给药前以及给药后0.75、2、4、8、10和12小时测量的斯旺森、科特金、阿格勒、M - 弗林和佩勒姆（SKAMP）综合评定量表以及永久性学业成绩指标（PERMP）数学测试。安全性评估包括体格检查、筛查心电图（ECG）、生命体征、临床实验室检查、不良事件测量以及使用哥伦比亚自杀严重程度评定量表进行自杀倾向评估。
结果
在完成治疗者（n = 39）中，与安慰剂（均值 = 19.58）相比，NWP06在给药后4小时使SKAMP综合评分有显著改善（p < 0.0001）（均值 = 7.12）。在每个测试时间点（0.75、2、4、8、10、12小时）NWP06与安慰剂均有显著差异，NWP06在给药后45分钟起效，疗效持续至给药后12小时。NWP06治疗后的不良事件（AE）和生命体征变化一般较轻，与已知的哌甲酯安全性特征相符。开放标签阶段最常见的不良事件为食欲减退（55.6%）、上腹部疼痛（42.2%）、情绪不稳定（26.7%）、初始失眠（22.2%）、失眠（17.8%）以及头痛（17.8%）。
结论
NWP06治疗可有效减轻儿童ADHD症状，给药后45分钟开始起效并持续12小时。NWP06耐受性良好。
试验注册
ClinicalTrials.gov标识符：NCT00904670。http://www.clinicaltrials.gov/ct2/show/NCT00904670 。
Zotero 插件