A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 主要终点
- The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit.
研究概览
简要总结
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.
详细描述
This is a phase III, randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose optimization study designed to evaluate the safety and efficacy of MTS (12.5, 18.75, 25, and 37.5 cm2) compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with attention deficit hyperactivity disorder (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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •male or female aged 6-12 years
- •females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline.
- •a primary diagnosis of ADHD based on a detailed psychiatric evaluation
- •a total score of =>26 on the ADHD-RS-IV at the Baseline Visit
- •a minimum level of intellectual functioning, as determined by an IQ (based on KBIT) score of 80 or above
- •no comorbid illness that could affect safety or tolerability or in any way interfere with the subject's participation in the study.
- •EXCLUSION CRITERIA:
- •a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD) with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
- •a known non-responder to psychostimulant treatment
- •overweight (Body Mass Index (BMI)-for-age >90th percentile)
- •a history of seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- •Conduct Disorder.
- •Subject has taken an investigational drug within 30 days prior to Screening.
排除标准
- 未提供
研究组 & 干预措施
Methylphenidate Transdermal System
Methylphenidate 2.7mg, 41.3mg, 55mg, and 82.5mg patches for 7 weeks
干预措施: Methylphenidate Transdermal System (Drug)
Placebo
Placebp matching MTS and Concerta for 7 weeks
干预措施: Placebo (Drug)
Concerta
Methylphenidate HCL 18mg tablet 7 weeks
干预措施: Concerta (Drug)
结局指标
主要结局
The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit.
时间窗: 7 weeks
次要结局
- CTRS-R, CPRS-R, CGI, PGA scores(7 weeks)
- Treatment emergent AEs, dermal evaluations, PK(7 weeks)