NCT01325220已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Children With Fragile X Syndrome
Seaside Therapeutics, Inc.28 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 28
- 主要终点
- Aberrant Behavior Checklist-Lethargy Social Withdrawal subscale
研究概览
简要总结
There will be four study periods: Screening (up to 14 days in length), the Treatment Period (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects will be randomized to receive either STX209 (5 mg twice daily [BID], 10 mg BID or 10 mg three times daily [TID]) or placebo. Efficacy,safety and tolerability assessments will be performed periodically
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Molecular documentation of the full FMR1 mutation
- •Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.
- •Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics.
- •If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening
排除标准
- •Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
- •Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
- •Subjects who have taken another investigational drug within the last 30 days.
- •Subjects who are not able to take oral medications
研究组 & 干预措施
STX209 5 mg BID
Active Comparator
干预措施: arbaclofen (Drug)
STX209 10 mg BID
Active Comparator
干预措施: arbaclofen (Drug)
STX209 10 mg TID
Active Comparator
干预措施: arbaclofen (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Aberrant Behavior Checklist-Lethargy Social Withdrawal subscale
时间窗: at 8 weeks of treatment
This is a single subscale of the aberrant behavior checklist entitiled Lethargy Social Withdrawal
次要结局
未报告次要终点
研究者
研究点 (28)
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