Phase II, Open-label, Dose-titration, Safety Study Designed to Determine the Evening Dose of a Novel Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) to Produce Optimal Clinical Effects in Children With ADHD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Dose Escalation to determine optimal dosage for clinical effects
研究概览
简要总结
The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design.
详细描述
This dose-escalation study will examine HLD100 in 24 subjects.
The subjects (n=24) will be tested with HLD100 in ascending doses from 10mg up to 40mg.
This study will be divided into several phases: Screening, Active Treatment and Follow-Up. All visits have a 2 day window to allow for scheduling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must have a diagnosis of ADHD as defined by DSM-5 criteria with confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- •Subjects must demonstrate mild-to-moderate impairment of ADHD symptoms and function per the following at screening (V1) and/or baseline (V2):
- •ADHD-RS-IV score at or above the 90th percentile normalized for sex and age in total score and ≥24 at Baseline;
- •CGI-S score ≥4;
- •Subject body weight must be ≥20 kg.
- •Subject must be considered clinically appropriate for treatment with amphetamine and HLD100, including prior treatment experience with an amphetamine product, and ability to swallow treatment capsules.
排除标准
- •History of, or current, medical condition or laboratory result which, in the opinion of the investigator, unfavorably alters the risk-benefit of study participation, may jeopardize subject safety, or may interfere with the satisfactory completion of the study and study-related procedures.
- •Serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- •History of seizure disorder (except febrile seizures prior to age 5 and with last occurrence at least 1 year prior to study participation), Tourette's disorder, or intellectual disability of minor severity or greater (DSM-5 criteria).
- •History of psychosis, bipolar disorder, anorexia nervosa, bulimia, or suicide attempt. Current depression, anxiety, conduct/behavior disorder, substance use disorder, or other psychiatric condition which, in the investigator's opinion, may jeopardize subject safety or may interfere with the satisfactory completion of the study and study-related procedures.
- •Active suicidal ideation as evidenced by an ideation score of 2 or greater on the C-SSRS.
- •History of severe allergic reaction or intolerance to amphetamine.
研究组 & 干预措施
HLD100 10mg
HLD100 (dextroamphetamine sulfate) DR/ER capsules (10mg)
干预措施: HLD100 (Drug)
HLD100 20mg
HLD100 (dextroamphetamine sulfate) DR/ER capsules (20mg)
干预措施: HLD100 (Drug)
HLD100 30mg
HLD100 (dextroamphetamine sulfate) DR/ER capsules (30mg)
干预措施: HLD100 (Drug)
HLD100 40mg
HLD100 (dextroamphetamine sulfate) DR/ER capsules (40mg)
干预措施: HLD100 (Drug)
结局指标
主要结局
Dose Escalation to determine optimal dosage for clinical effects
时间窗: 6 weeks
Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner
次要结局
- Safety (AEs, ECG, laboratory parameters, physical examinations)(48 hours)