NCT00151957已完成3 期
A Phase III, Multi-center, Open-label Study of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Noven Therapeutics0 个研究点目标入组 450 人开始时间: 2004年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 主要终点
- Treatment emergent adverse events over 12 months.
研究概览
简要总结
This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD
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 evaluate the long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed with ADHD
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 participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-
- •Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures.
- •Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.
排除标准
- •Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols
- •Female subject is pregnant or lactating
研究组 & 干预措施
Methylphenidate transdermal system
Experimental
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
干预措施: Methylphenidate Transdermal System (Drug)
结局指标
主要结局
Treatment emergent adverse events over 12 months.
时间窗: Weekly
次要结局
- ADHD-RS-IV scores(Weekly)
- Parent Global Assessment(Weekly)
- Clinical Global Impressions Scale(Weekly)
- Child's Sleep Habits Questionnaire(Weekly)
研究者
相似试验
已完成
3 期
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JPRheumatoid ArthritisNCT00144547Chugai Pharmaceutical241
已完成
3 期
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JPRheumatoid ArthritisNCT00144534Chugai Pharmaceutical115
已完成
3 期
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JPRheumatoid ArthritisNCT00144586Chugai Pharmaceutical42
已完成
3 期
A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular LymphomaLymphoma, FollicularNCT02569996Hoffmann-La Roche124
进行中（未招募）
3 期
A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension PeriodPediatric Pyruvate Kinase DeficiencyPediatric Hemolytic AnemiaNCT05175105Agios Pharmaceuticals, Inc.30