NCT00500149已完成3 期
A Phase IIIb, Randomized, Double-Blind, Multi-Center, Placebo- Controlled, Dose-Optimization, Cross-Over, Analog Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder
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
- Shire
- 入组人数
- 129
- 试验地点
- 7
- 主要终点
- Onset of Effect of Vyvanse
研究概览
简要总结
The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) 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
- Crossover
- 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
- •Subject is a male or female aged 6-12 years inclusive at the time of consent.
- •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 and agree to comply with any applicable contraceptive requirements of the protocol.
- •Primary diagnosis of ADHD: combined sub-type or predominantly hyperactive impulsive sub-type based on a detailed psychiatric evaluation.
- •Subject has a baseline ADHD-RS-IV score ≥
- •Intelligent Quotient (IQ) score of 80 or above on the Kaufman Brief Intelligence Test (KBIT).
- •Subject must be able to complete at least the Basic Test of the PERMP assessment.
排除标准
- •Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis 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
- •Subject has Conduct Disorder.
- •Subject has a documented allergy, hypersensitivity or intolerance to amphetamines.
- •Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
- •The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.
- •Subject weighs less than 50 pounds (22.7kg).
- •Subject is significantly overweight
- •Subject had a history of seizures during the last two years (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- •Subject has any reported history of abnormal thyroid function.
- •Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
- •Subject has a known history of structural cardiac abnormality, as well as any other condition(s) that may affect cardiac performance.
- •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
- •Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics (bronchodilators are not exclusionary).
- •The female subject is pregnant or lactating.
- •Subject is well controlled on their current ADHD medication with acceptable tolerability.
研究组 & 干预措施
1
Experimental
干预措施: Vyvanse (lisdexamfetamine dimesylate) (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Onset of Effect of Vyvanse
时间窗: Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.
The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal).
次要结局
- Duration of Effect of Vyvanse(Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
2 期
A Phase 2 Study of Vapendavir in Asthmatic Adults With Symptomatic Human Rhinovirus InfectionAsthmaNCT02367313Biota Pharmaceuticals, Inc.455
已完成
4 期
Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity DisorderAttention-deficit/Hyperactivity DisorderNCT01552915Shire464
已完成
4 期
Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity DisorderAttention-deficit/Hyperactivity DisorderNCT01552902Shire549
已完成
4 期
Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)Attention Deficit Hyperactivity DisorderNCT01070394NYU Langone Health40
已完成
3 期
Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)Hepatitis C, ChronicNCT01370642Merck Sharp & Dohme LLC294