A Prospective, Open-Label, Multi-Center Study Evaluating the Safety and Tolerability of Methylphenidate Transdermal System (MTS) in Children Aged 6-12 Previously Treated With Extended-Release Methylphenidate Product.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 18
- 主要终点
- Score on ADHD Rating Scale at 4 weeks
研究概览
简要总结
This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
详细描述
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the safety and tolerability of SPD485 while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject must have a primary diagnosis of ADHD
- •Subject must be adequately controlled on a stable dose of one of the following medications for a 30 day period: Ritalin LA(r), Concerta(r), or Metadate DC(r), not to exceed 54 mg per day
- •Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin pregnancy test
排除标准
- •A history of mental retardation that would indicate that the subject is not functioning at an age appropriate level intellectually
- •A recent history of suspected substance abuse or dependence disorder
- •Subject is taking Strattera
- •Clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites
研究组 & 干预措施
Methylphenidate Transdermal System
Methylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks
干预措施: Methylphenidate Transdermal System (Drug)
Placebo patch
Placebo patch applied daily for 8 weeks
干预措施: Methylphenidate Transdermal System (Drug)
结局指标
主要结局
Score on ADHD Rating Scale at 4 weeks
时间窗: 30 days
次要结局
- Parent Global Assessment(30 days)
- Medication Satisfaction Survey(30 days)
- Parent rating scale(30 days)
- ADHD Impact Module(30 days)
- Clinical Global Impressions Scale(30 days)
- Adverse events, lab tests, dermal evaluations, ECGs(30 days)