Driving Performance in Patients Aged 18 to 25 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) After a Single-Dose of Amphetamine Extended-Release Tablets: A Pilot, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in Composite Reaction Time Score
研究概览
简要总结
The purpose of this study is to assess the effect on driving performance of a single dose of amphetamine extended-release tablets (20 mg/tablet) compared with placebo at 45 minutes and 10 hours post-dose in young adults with ADHD.
详细描述
At a single US-based study site, a driving simulation will be used to assess the effect on driving performance for the co-primary endpoints, study subjects' driving performance at 45 minutes and 10 hours post-dose, compared with placebo. Eligible subjects will be prescreened for ADHD but otherwise healthy, aged 18-25 years.
Driving simulations that simulate common driving events to which the study subject must react. The reactions to each event will be assessed. Using a parallel-group design, subjects will be assessed while on study drug, and while on placebo.
Safety assessments will include spontaneously reported treatment-emergent adverse events and vital signs at 4 hours post-dose.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 to 25 years, inclusive, at the time of screening who have a valid driver's license.
- •Normal visual acuity (either uncorrected or corrected with glasses, contact lenses or surgery) at Screening based upon clinical assessment of the Investigator
- •Diagnosed with ADHD using the Diagnostic and Statistical Manual of Mental Disorders Version 5 (DSM-5) criteria based on ADHD module from the Mini-International Neuropsychiatric Interview (M.I.N.I) version 7.0.
- •IQ within normal range based upon clinical assessment of the Investigator.
- •For female participants, presently using an acceptable method of contraception based upon clinical assessment of the Investigator.
- •Willing to abstain from using any forms of cannabinoids (THC, CBD, hemp oil, etc.) for 2 weeks prior to the Driving Simulation Visit (if applicable).
- •Be able to understand, read, write, and speak English fluently to complete the study related materials.
- •Be informed of the nature of the study and give written consent prior to any study procedure.
排除标准
- •Current or lifetime history of bipolar disorder or any psychotic disorder.
- •Current active symptoms of major depression generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, or post-traumatic stress disorder based upon clinical assessment of the Investigator.
- •Known history of chronic medical illnesses including known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, and known family history of sudden death.
- •History of uncontrolled hypertension or a resting systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg. Patients with well-controlled hypertension on a stable dose for at least 3 months of anti-hypertensives will be allowed to participate.
- •Have clinically significant findings in vital signs measurements at Screening including:
- •Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg (average of triplicate measurements)
- •Heart rate >100 bpm (average of triplicate measurements)
- •Known history or presence of significant renal or hepatic disease.
- •Use of monoamine oxidase inhibitors (MAOI), e.g. selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue, within 14 days of the Driving Simulator Visit.
- •Use of ADHD medications including all stimulants (methylphenidate, amphetamine or derivatives of any of these products), within 48 hours of the Driving Simulator Visit.
- •Participation in a clinical study in which an investigational drug was administered within 30 days prior to Screening.
- •Known history of allergy/hypersensitivity to amphetamine or any of the components of the test products.
- •Known history of lack of clinical response to amphetamine based upon Investigator assessment
- •Any uncontrolled medical condition that, in the opinion of Medical Monitor or Sponsor, would preclude study participation.
- •History or presence of alcohol dependence or substance abuse disorder or within the last 6 months based upon clinical assessment of the Investigator.
- •Positive urine pregnancy test at Driving Simulator Visit
- •Positive breath alcohol test at Driving Simulator Visit.
- •Patient's inability or unwillingness to follow directions from the study research staff.
研究组 & 干预措施
Amphetamine ER Tablets, 20 mg
Double-blind amphetamine extended-release tablets, 20 mg dose, single tablet, administered at baseline
干预措施: Amphetamine Extended Release (ER) Tablet 20 mg (Drug)
Placebo
Matching double-blind placebo tablets, 20 mg dose, single tablet, administered at baseline
干预措施: Amphetamine Extended Release (ER) Tablet 20 mg (Drug)
结局指标
主要结局
Change in Composite Reaction Time Score
时间窗: Measured at pre-dose, 45 minutes and 3 hours post-dose
Measurement of reaction time across a series of driving simulations
次要结局
未报告次要终点