An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Autism Spectrum Disorders
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Irritability subscale of the Aberrant Behavior Checklist
研究概览
简要总结
Study 22003, "An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD)" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with ASD. This study (22007) will enter subjects who complete Study 22003 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with ASD who receive treatment under conditions more closely reflective of their general medical care.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed all scheduled visits in protocol 22003 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with STX209, as assessed by the principal investigator
排除标准
- •Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
- •The occurrence or continuation of any adverse event or condition during study 22003 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension
研究组 & 干预措施
STX209
STX209 (arbaclofen)
干预措施: arbaclofen (Drug)
结局指标
主要结局
Irritability subscale of the Aberrant Behavior Checklist
时间窗: every 2 to 3 months
次要结局
未报告次要终点