A Phase II Study to Assess the Safety, Tolerability and Efficacy of SPD503 Administered to Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 182
- 主要终点
- Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks
研究概览
简要总结
The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a primary diagnosis of ADHD
- •Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =>4
- •Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
- •Subject weighs > 55 lbs and is not morbidly overweight
排除标准
- •Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
- •Subject has a history of seizure disorder
- •Subject has any specific cardiac condition or family history of significant cardiac condition
- •Subject is pregnant, lactating or within six month post-partum
研究组 & 干预措施
SPD503 (Guanfacine HCl)
干预措施: SPD503 (Guanfacine HCl) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks
时间窗: Baseline and 6 weeks
Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.
次要结局
- Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks(Baseline and 6 weeks)
- Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years(Baseline and 6 weeks)
- Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years(Baseline and 6 weeks)
- Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks(Baseline and 6 weeks)
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks(Baseline and 6 weeks)
- Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks(6 weeks)
- Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks(Baseline and 6 weeks)