Biomarker Testing and DNA Collection in Subjects Participating in a Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 11
- 主要终点
- change in plasma proteins with treatment
研究概览
简要总结
The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 will be offered participation in 22001A which will evaluate secreted protein before and after treatment with STX209 and placebo to determine if they correlate with effectiveness of treatment or susceptibility to treatment with STX209. These same subjects will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection. The investigators will study the DNA to determine if STX209 works better in people with specific gene variations, or to find new gene variations that predict how well STX209 works.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 40 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001
排除标准
- •Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001
研究组 & 干预措施
Arbaclofen followed by Placebo
干预措施: STX209 (Drug)
Placebo followed by Arbaclofen
干预措施: STX209 (Drug)
结局指标
主要结局
change in plasma proteins with treatment
时间窗: After 4 weeks of treatment
次要结局
未报告次要终点
