NCT00499863已完成3 期
A Phase IIIb, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Efficacy and Safety of MTS in Adolescents Aged 13-17 Years With ADHD
Noven Therapeutics30 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2007年7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
- 217
- 试验地点
- 30
- 主要终点
- Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint
研究概览
简要总结
To assess the efficacy and safety of efficacy of MTS compared to placebo
详细描述
To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with 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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must meet criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
- •Subject must have a total score of ≥26 on the ADHD-RS-IV at the Baseline Visit (Visit 2).
- •Subject must have a minimum level of intellectual functioning, as determined by an IQ (based on Kaufman Brief Intelligence Test [KBIT]) score of 80 or above.
- •Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
- •Subject is a male or female aged 13 17 years.
- •Females must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to use acceptable contraceptives throughout the study period and for 30 days after the last dose of IP.
排除标准
- •Subject has a current, controlled (requiring a restricted medication) or uncontrolled, with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder.
- •Subjects who, in the opinion of the Investigator, are acutely at risk for suicidal or violent behavior towards him/herself or others, or a history of a suicide attempt requiring medical intervention.
- •Subject is overweight.
- •Subject has a history of seizures during the last 2 years, a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- •Subject has Conduct Disorder.
- •Subject has a positive urine drug or alcohol result at Screening (with the exception of subject's current stimulant therapy, if any).
- •Subject has a history of alcohol or other substance abuse or dependence.
- •Subject has taken an investigational drug within 30 days prior to screening.
- •Subject has any abnormal thyroid function.
- •Subject has any clinically significant laboratory abnormalities.
- •Subject has severe allergic rhinitis, disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Mild, stable asthma is not exclusionary.
- •The female subject is pregnant or lactating.
- •Subject has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions which would interfere with trial assessments or compromise subject safety (e.g. dermatitis, eczema or psoriasis).
- •Subject has sensitive-skin syndrome (definition: subjects who often develop nonspecific skin irritancy reactions to bland materials) or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
- •Subject has clinical signs and symptoms of skin irritation (i.e., pruritus, burning, erythema) or scars or tattoos.
研究组 & 干预措施
Methylphenidate Transdermal System
Experimental
dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear
干预措施: methylphenidate transdermal system (Drug)
2
Placebo Comparator
Daily application of matching MTS Placebo Patch
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint
时间窗: baseline and endpoint (up to 7 weeks)
The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
次要结局
- Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint(Baseline and endpoint (up to 7 weeks))
- Improvement in Clinical Global Impressions-Improvement (CGI-I) Score(up to 7 weeks)
- Improvement in Parent Global Assessment (PGA) Score(up to 7 weeks)
- Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint(Baseline and endpoint (up to 7 weeks))
- Dermal Response Scale (DRS) Scores(up to 7 weeks)
- Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint(Baseline and endpoint (up to 7 weeks))
- Change From Baseline in Pulse Rate at Endpoint(Baseline and endpoint (up to 7 weeks))
- Change From Baseline in Systolic Blood Pressure at Endpoint(Baseline and endpoint (up to 7 weeks))
- Change From Baseline in Diastolic Blood Pressure at Endpoint(Baseline and endpoint (up to 7 weeks))
- Change From Baseline in Weight at Endpoint(Baseline and endpoint (up to 7 weeks))
研究者
研究点 (30)
Loading locations...
相似试验
已完成
3 期
Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHDAttention Deficit Hyperactivity DisorderNCT00444574Noven Therapeutics282
进行中（未招募）
3 期
To Compare the Efficacy of the Addition of Methotrexate (MTX) to Current Standard Acute Graft-versus-host Disease (GVHD) First-line Treatment With CorticosteroidsAllogeneic DiseaseGVH - Graft Versus Host ReactionGVHD, AcuteStem Cell Transplant ComplicationsNCT03371667Assistance Publique - Hôpitaux de Paris102
已完成
3 期
Efficacy and Safety of Losartan/Chlorthalidone vs Losartan/Hydrochlorothiazide in Essential Arterial HypertensionEssential Arterial HypertensionNCT04927299Laboratorios Silanes S.A. de C.V.163
已完成
2 期
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative ColitisUlcerative ColitisNCT04857112Bausch Health Americas, Inc.322
已完成
2 期
Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord InjurySpinal Cord InjuryNCT04683848Tanabe Pharma America, Inc.72