NCT00466791已完成2 期
A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Optimization, Analog Classroom, Crossover Study Designed to Assess the Time Course of Treatment Effect, Tolerability and Safety of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Noven Therapeutics1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2004年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS
研究概览
简要总结
Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD
详细描述
Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis ADHD
- •Total score of greater than or equal to 26 on ADHD-RS-IV
- •IQ of greater than or equal to 80
- •Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline
排除标准
- •Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD)
- •Known nonresponder to psychostimulant treatment
- •BMI for age greater than 90th percentile
- •History of seizures during last 2 years
- •Conduct Disorder
研究组 & 干预措施
Methylphenidate Transdermal System
Active Comparator
Transdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks
干预措施: Methylphenidate Transdermal System (Drug)
Placebo
Placebo Comparator
Transdermal patch, 0mg, daily for 11 weeks
干预措施: Methylphenidate Transdermal System (Drug)
结局指标
主要结局
Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS
时间窗: 2,3,4.5,6,7.5,9,10.5 and 12 hours
次要结局
- Clinician-rated ADHD-RS-IV score(2,3,4.5,6,7.5,9,10.5 and 12 hours)
- CGI-I score(Weeks 1-9)
- CPRS-R score(Weeks 1-9)
- PERMP scores(pre-dose, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5 and 12.0 hours post application)
- PGA(Weeks 1-9)
研究者
研究点 (1)
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