EUCTR2011-004349-42-GB进行中（未招募）1 期
A randomized, double-blind, 12- week, parallel group, placebo-controlled study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 183
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adults and adolescents (14 to 50)
- •CGI-S of 3 (mildly ill) or more
- •ABC total score of 20 or more
- •Diagnosis of FXS with a confirmed FMR1 full mutation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Have previously received treatment with another mGlu5 receptor antagonist within 18 months or RO4917523
- •Enrollment/participation in any interventional study (clinical trial) involving an investigational drug (unapproved) or non-drug treatment within the prior 3 months or 5 times the half-life (whichever is longer)
- •Any uncontrolled, unstable clinically significant psychiatric condition other than FXS that may interfere with interpretation of safety and efficacy evaluations (e.g. Attention Deficit Hyperactivity Disorder (ADHD))
- •Current symptoms or presumption of psychosis or euphoria, history of catatonia, hallucinations or delusional thoughts
- •History of suicidal behaviour or otherwise considered a high suicidal risk by the investigator
研究者
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