NCT02024789已完成2 期
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF RG1662 IN ADULTS AND ADOLESCENTS WITH DOWN SYNDROME (CLEMATIS)
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
- 173
- 试验地点
- 37
- 主要终点
- Cognition as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) sub-tests
研究概览
简要总结
This multi-center, randomized, double-blind, 3-arm, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RG1662 in adults and adolescents with Down syndrome. Subjects will be randomized to receive RG1662 either at low or high dose or placebo orally twice daily for 26 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
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 12-30 years of age inclusive
- •Clinical diagnosis of Down syndrome (trisomy 21) confirmed by chromosomal analysis (karyotyping)
- •Males, or non-pregnant, non-lactating females. For females of childbearing potential, strict contraceptive prevention is required.
- •Body-mass Index (BMI) 18-42 and 15-30 kg/m2 inclusive for adults and adolescents respectively
- •Ability to complete the Clinical Evaluation of Language Fundamentals (CELF)-preschool 2 word classes task
- •Subjects must have a parent, or other reliable caregiver who agrees to accompany the subject to all clinic visits, provide information about the subject as required by the protocol, and ensure compliance with the medication schedule
- •Study participants must have sufficient language, vision and hearing to participate in study evaluations, as judged clinically by investigator
排除标准
- •Subjects with a current DSM 5 diagnosis of any primary psychiatric diagnosis (including ASD or MDD)
- •Subjects with a history of infantile spasms, of West syndrome, Lennox-Gastaut syndrome, Early Infantile Epileptic Encephalopathy or any treatment-refractory epilepsy associated with cognitive or developmental regression, of severe head trauma or CNS infections (e.g. meningitis)
- •Subjects with a known or suspected clinical seizure event of any type within 24 months prior to screening
- •Clinically relevant ECG abnormalities at screening or baseline; QTcF above 450 ms; personal or family history (first degree relatives) of congenital long QT syndrome
- •Inadequate renal or hepatic function
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
RG1662 120 mg bid
Experimental
干预措施: RG1662 (Drug)
RG1662 240 mg bid
Experimental
干预措施: RG1662 (Drug)
结局指标
主要结局
Cognition as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) sub-tests
时间窗: 26 weeks
Adaptive behavior as assessed by the Vineland Adaptive Behavior Scales-II (VABS-II) standard scores
时间窗: 26 weeks
Clinical global impression as assessed by Clinician Rated Global Improvement (CGI-I) scale
时间窗: 26 weeks
次要结局
- Abnormal ECG changes in adolescents as compared to baseline(from baseline to Week 26)
- Safety: Incidence of adverse events(approximately 32 weeks)
- RG1662 plasma concentrations(26 weeks)
- Incidence of abnormal blood pressure(26 weeks)
- Incidence of abnormal ECG changes(26 weeks)
研究者
研究点 (37)
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