An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 37
- 主要终点
- Frequency of occurrence of treatment-emergent adverse events (TEAEs).
研究概览
简要总结
ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002. The primary objective of the study will be to evaluate the safety of ML-004 in subjects 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
- 12 Years 至 46 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has completed Study ML-004-002 within the past 90 days
- •Age 12 years to 46 years at screening
- •Has a designated care/study partner who can reliably report on symptoms
- •Has a diagnosis of Autism Spectrum Disorder (ASD)
- •Has a body mass index (BMI) ≥18 kg/m²
- •Psychoactive medications and adjunctive therapies stable for 4 weeks prior to screening
- •Must be able to swallow study medication
排除标准
- •Has Rett syndrome or Child Disintegrative Disorder
- •History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
- •Has a positive response to C-SSRS questions 4 and/or 5, or is a significant risk for suicidal behavior
- •Has a clinical history of uncontrolled or severe hypertension
- •If female, is pregnant or lactating
研究组 & 干预措施
ML-004 (IR)/(ER) tablet
ML-004 is a bilayer immediate-release (IR)/extended-release (ER, gastroretentive) oral tablet formulation. ML-004 is taken orally once daily and provided as a tablet in two dose strengths of 12 mg (3 mg IR/9 mg ER) and 24 mg tablet (6 mg IR/18 mg ER). Dose levels for this study are 12 mg (provided as one 12 mg tablet), 24 mg (one 24 mg tablet), 48 mg (two 24 mg tablets), and 72 mg (three 24 mg tablets).
干预措施: ML-004 (IR)/(ER) tablet (Drug)
结局指标
主要结局
Frequency of occurrence of treatment-emergent adverse events (TEAEs).
时间窗: Baseline up to Day 362
次要结局
- Frequency of occurrence of TEAEs arising from clinically important changes in other safety assessments.(Baseline up to Day 362)
- Frequency of occurrence of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale.(Baseline up to Day 362)
- Frequency of occurrence of Serious Adverse Events (SAEs)(Baseline up to Day 362)
- Frequency of occurrence of TEAEs leading to discontinuation.(Baseline up to Day 362)