An Open-label Study Evaluating DT402 in Adults With Autism Spectrum Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from Baseline in 11-point Numerical Rating Scale (NRS) scores
研究概览
简要总结
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
详细描述
This study will enroll approximately twenty adults with Autism Spectrum Disorder (ASD) aged 18 to 65 years of age.
This is a multi-center, open-label study to evaluate the effects after a single administration of DT402 to adults with ASD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ASD per records as confirmed by standard semi-structured interview for Autism diagnosis (eg, Autism Diagnostic Observation Schedule-Second Edition)
- •Male or Female aged 18 to 65
- •Presents with clinically significant deficits in socialization and communication as determined by Social Responsiveness Scales (SRS-2) ≥66
排除标准
- •Has uncorrected abnormalities in eye movement, alignment, or acuity or atypical eye features that could interfere with eye tracking
- •First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
- •Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
- •Any clinically significant unstable illness
研究组 & 干预措施
200 mg DT402
A psychoactive substance that mediates effects mainly through a release of the monoaminergic neurotransmitters, with the greatest effect on 5-HT, followed by NE and DA
干预措施: DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA)) (Drug)
结局指标
主要结局
Change from Baseline in 11-point Numerical Rating Scale (NRS) scores
时间窗: Baseline, pre-dose and 2, 4, 6, 8, and 24 hours post-dose and day 15
The NRS is an 11-point PRO scale used to measure the severity or intensity of effects from 0 (no effect) to 10 (high severity or intensity of effect). It consists of various items related to both positive and negative effects in the autism patient population.
次要结局
- Pharmacokinetic Parameters (AUC0-24h)(pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose)
- Subjective 5-question Drug Effects Questionnaire (DEQ) scores(1, 2, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetic Parameters (Tmax)(pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetic Plasma concentrations(pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetic Parameters (Cmax)(pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetic Parameters (t1/2)(pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose)
- Pharmacokinetic Parameters (AUC0-inf)(pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose)