NCT01517698已完成2 期
A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 185
- 主要终点
- Change in Anxiety Depression and Mood Scale (ADAMS) total score
研究概览
简要总结
This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult and adolescent patients, 14-50 years of age
- •Diagnosis of fragile X syndrome with a confirmed fragile X mental retardation 1 (FMR1) full mutation and qualifying scores on the Aberrant Behavior Checklist (ABC) and CGI-S
- •Patients must agree to either remain completely abstinent or to use two effective contraceptive methods during and 3 weeks after the study
排除标准
- •Previous treatment with another metabotropic glutamate (mGLU) receptor antagonist within 18 months or with RO4917523
- •Participation in a clinical trial involving an investigational (unapproved) drug within 3 months or 5 times the half-life (whichever is longer) before start of this study
- •Any uncontrolled, unstable clinically significant psychiatric condition other than fragile X syndrome
- •History of suicidal behavior
研究组 & 干预措施
RO4917523 0.5 mg
Experimental
干预措施: RO4917523 0.5 mg (Drug)
RO4917523 1.5 mg
Experimental
干预措施: RO4917523 1.5 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Anxiety Depression and Mood Scale (ADAMS) total score
时间窗: 12 weeks
Safety (incidence of adverse events)
时间窗: 12 weeks
次要结局
- Change in Social Responsiveness Scale (SRS)(12 weeks)
- Change in Clinical Global Impressions Scale - Improvement (CGI-I)(12 weeks)
- Change in Clinical Global Impressions Scale - Severity of Illness (CGI-S)(12 weeks)
- Change in Aberrant Behavior Checklist total score(12 weeks)
- Change in Aberrant Behavior Checklist factor scores(12 weeks)
- Change in Anxiety Depression and Mood Scale (ADAMS) factor scores(12 weeks)
研究者
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