NCT01834638终止2 期
Long-Term Safety and Efficacy of ABT-126 in Subjects With Schizophrenia: A Double-Blind Extension Study for Subjects Completing Study M10-855
AbbVie51 个研究点 分布在 3 个国家目标入组 268 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 268
- 试验地点
- 51
- 主要终点
- Percentage of subjects with adverse events
研究概览
简要总结
This is a study of ABT-126 in the treatment of cognitive impairment associated with schizophrenia (CIAS), a long-term extension study to study M10-855 (NCT01655680).
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
- 20 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject was randomized into Study M10-855 and completed through Week 26 in that study.
- •The subject is receiving one or more antipsychotic medications.
排除标准
- •Additional history collected during participation in Study M10-855 provides evidence that, in the investigator's judgement, the subject does not have schizophrenia.
- •The subject experienced an adverse event or abnormal finding during physical examination, vital signs, laboratory profile, and/or electrocardiogram (ECG) measurements in Study M10-855 that indicates the subject is likely to become medically unstable during the current study.
- •The subject is currently taking or is expected to be prescribed any excluded medication without the approval of AbbVie medical monitor.
- •The subject is currently enrolled in, or plans to participate in, another interventional study during the course of this trial.
研究组 & 干预措施
ABT-126 low dose
Experimental
ABT-126 low dose
干预措施: ABT-126 (Drug)
ABT-126 middle dose
Experimental
ABT-126 middle dose
干预措施: ABT-126 (Drug)
ABT-126 high dose
Experimental
ABT-126 high dose
干预措施: ABT-126 (Drug)
结局指标
主要结局
Percentage of subjects with adverse events
时间窗: up to 52 weeks
Change in laboratory test results
时间窗: from Day -1 to Week 52
Change in vital signs
时间窗: from Day -1 to Week 52
Change in electrocardiogram (ECG) data
时间窗: from Day -1 to Week 52
次要结局
- Change in the Positive and Negative Syndrome Scale (PANSS)(from Day -1 to Week 52)
- Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)(from Day -1 to Week 52)
- Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER)(from Day -1 to Week 52)
- Change in the 16-item version of the Negative Symptom Assessment Scale (NSA-16)(from Day -1 to Week 52)
研究者
研究点 (51)
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