A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years 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
- 163
- 试验地点
- 30
- 主要终点
- Diastolic Blood Pressure
研究概览
简要总结
To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD
详细描述
To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in the symptomatic treatment of adolescents aged 13-17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The evaluation of safety will be based on treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs), and skin tolerability to MTS based on the dermal response score (DRS).
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for inclusion, each subject must fulfill each of the following criteria at the Entry visit:
- •The subject participated in the antecedent SPD485-409 study, and a) completed all required study visits (Baseline through Visit 9) OR b) completed the 5 week Dose Optimization period without achieving an acceptable condition as defined by the antecedent SPD485-409 study.
- •Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Entry.
- •Subject's ECG results are within the normal range or not clinically significant at Entry as judged by the Investigator in conjunction with the central reader.
- •Females must have a negative urine pregnancy test at Entry and agree to use acceptable contraceptives throughout the study period and for 30 days the last dose of IP.
- •Subject and parent of legally authorized representative (LAR) are able, willing and likely to fully comply with study procedures and restrictions.
- •Written, signed and dated informed consent to participate in the study must be given by the subject's parent or LAR, in accordance with the International Conference on Harmonisation (ICH), Good Clinical Practices (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
- •There must be documentation of the subject's assent to participate in the study indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions. Failure to object is not to be considered assent.
- •Exclusion Criteria
- •Subjects will be excluded from the study if any of the following criteria are met at Entry:
- •Subject was discontinued from SPD485-409 due to a protocol violation, non-compliance, AE, or a serious adverse event (SAE).
- •Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
- •Subject is taking any medication that is excluded.
- •Female subject who is pregnant or lactating.
排除标准
- 未提供
研究组 & 干预措施
1
Methylphenidate Transdermal System
干预措施: Methylphenidate Transdermal System (Drug)
结局指标
主要结局
Diastolic Blood Pressure
时间窗: Baseline and 6 months
Pulse Rate
时间窗: Baseline and 6 months
Post Sleep Questionnaire (PSQ) Quality of Sleep
时间窗: 6 months
Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.
Dermal Reactions
时间窗: 6 months
Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.
Electrocardiogram Results (QTcF Interval)
时间窗: Baseline and 6 months
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Systolic Blood Pressure
时间窗: Baseline and 6 months
Weight
时间窗: Baseline and 6 months
次要结局
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months(Baseline and 6 months)
- Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months(Baseline and 6 months)
- Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores(6 months)
- Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months(Baseline and 6 months)
- Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.(6 months)