NCT00697515已完成3 期
A Phase IIIb Randomized, Double-Blind, Multicenter, Placebo-Controlled, Dose Optimization, Crossover, Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
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
- 142
- 试验地点
- 5
- 主要终点
- Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase
研究概览
简要总结
To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting
详细描述
This study has both an optimization and double-blind period
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be 18-55 years of age, inclusive at the time of consent.
- •Female subjects 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.
- •Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria with at least 6 of the 9 subtype criteria met. The Adult ADHD Clinical Diagnostic Scale version 1.2 (ACDS v1.2) will be utilized as the diagnostic tool.
- •Subject has a Baseline score of > or equal to 28 using the Adult ADHD-RS with prompts.
- •Subject must have a minimum level of intellectual functioning, as determined by an Intelligent Quotient (IQ) score of 80 or above based on the Kaufman Brief Intelligence Test (KBIT).
排除标准
- •Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Comorbid psychiatric diagnoses will be established by the psychiatric evaluation that includes the Structured Clinical Interview for DSM-IV-TR disorders (SCID-I).
- •Subjects who are currently considered a suicide risk, any subject who has previously made a suicide attempt or those who are currently demonstrating active suicidal ideation.
- •Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
- •Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- •Subject has current abnormal thyroid function, as defined as abnormal Screening thyroid stimulating hormone. Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
- •Subject has a history of moderate to severe hypertension or has a resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg.
- •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.
- •Subject has glaucoma.
- •Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors (during or within 14 days of test or reference product administration). Stable use of bronchodilator inhalers is not exclusionary.
- •Subject is female and pregnant or lactating.
研究组 & 干预措施
Lisdexamfetamine Dimesylate (LDX, SPD489)
Active Comparator
干预措施: LDX (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase
时间窗: 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
次要结局
- ADHD-RS With Prompts Total Score in the Crossover Phase(7 days)
- Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase(26 days)
- PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase(2, 4, 8, 10, 12 and 14 hours post-dose on Day 7)
- PERMP Total Score by Timepoint in the Crossover Phase(2, 4, 8, 10, 12 and 14 hours post-dose on Day 7)
- PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase(2, 4, 8, 10, 12 and 14 hours post-dose on Day 7)
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase(Baseline and 7, 14, 21 and 28 days)
- Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase(Baseline)
- Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase(7, 14, 21 and 28 days)
- Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase(7 days)
- Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase(Baseline and 26 days)
- Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase(Baseline and 26 days)
- Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase(Baseline and 26 days)
- Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase(Baseline and 7, 14, 21 and 28 days)
- Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase(Baseline and 7, 14, 21 and 28 days)
- Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase(Baseline and 7, 14, 21 and 28 days)
- Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase(Baseline and 7 days)
研究者
研究点 (5)
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