A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 in Combination With Psychostimulants in Children and Adolescents Aged 6-17 Years With a Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 461
- 试验地点
- 58
- 主要终点
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks
- •Aged 6-17 years with a sub-optimal
- •Partial response to stimulants
- •Subjects must be < 95th percentile for BMI with weight >= 55lbs and <= 176lbs
排除标准
- 未提供
研究组 & 干预措施
SPD503-PM
SPD503 (Guanfacine Extended Release)
干预措施: SPD503-PM (Drug)
Placebo
干预措施: Placebo (Drug)
SPD503-AM
SPD503 (Guanfacine Extended Release)
干预措施: SPD503-AM (Drug)
结局指标
主要结局
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
时间窗: Baseline and weekly up to 8 weeks
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
次要结局
- Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF(Baseline and week 8)
- Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF(Baseline and weekly up to 8 weeks)
- Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF(Baseline and weekly up to 8 weeks)
- Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF(Baseline and weekly up to 8 weeks)
- Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF(Baseline and weekly up to 8 weeks)
- Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)(Baseline and weekly up to 8 weeks)
- Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF(Baseline and weekly up to 8 weeks)
- Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)(Baseline and weekly up to 8 weeks)