跳至主要内容
临床试验/NCT00823368
NCT00823368已完成不适用

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

Seaside Therapeutics, Inc.11 个研究点 分布在 1 个国家开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

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

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

研究者

发起方
Seaside Therapeutics, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (11)

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