An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 165
- 试验地点
- 25
- 主要终点
- Safety and tolerability of STX209
研究概览
简要总结
This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.
详细描述
This is an open label extension study enrolling by invitation only to those subjects that have completed Seaside protocols 209AS208 and 22007.
Protocol 209AS208, "A Randomized,Double-Blind, Placebo-Controlled, Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Subjects with Autism Spectrum Disorders."
Protocol 22007, "An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Autism Spectrum Disorder."
This open-label extension will provide data on the following:
- Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen)
- Provide supporting pharmacokinetic analyses
- Assess long term efficacy on social behaviors 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
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject completed study 22007 or 209AS208, and showed he can adequately follow the protocol, and with adequate medical justification to enter this study.
- •Parent or other legally-authorized representative or caregiver is willing and able to perform all protocol-specified functions.
- •Treatment with no more than 2 psychoactive medications
- •Subjects with a history of seizure disorder must be adequately well-controlled, as specified in the study protocol
- •For female subjects, negative pregnancy test
排除标准
- •Comorbid conditions that might interfere with the conduct of the study or confound the interpretation of the study data, or endanger the subject.
- •Current use of illicit drugs or alcohol abuse.
- •Subjects with a serious adverse event or other adverse event in study 22007 or 209AS208 that was related to STX209, and that endangers the subject, in the opinion of the investigator
- •Current use of another investigational drug, or of vigabatrin, tiagabine, or riluzole
研究组 & 干预措施
STX209
Active treatment with STX209
干预措施: STX209 (arbaclofen) (Drug)
结局指标
主要结局
Safety and tolerability of STX209
时间窗: 100 weeks
Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
次要结局
- Aberrant Behavior Checklist(100 weeks)