NCT01895452已完成3 期
A Phase 3, Multicenter Extension of Study ALK9072-003EXT to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 2
- 主要终点
- Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the treatment period of Study ALK9072-003EXT
- •Continues to require chronic treatment with an antipsychotic medication
- •Continues to reside in a stable living situation
- •Continues to have an identified reliable informant
排除标准
- •Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug
- •Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT
- •Has a significant or unstable medical condition that would preclude safe completion of the current study
- •Subject is pregnant or breastfeeding
- •Subject expects to be incarcerated, or has pending legal action which may impact compliance with study participation or procedures
研究组 & 干预措施
ALKS 9072, Low Dose
Experimental
干预措施: ALKS 9072, Low Dose (Drug)
ALKS 9072, High Dose
Experimental
干预措施: ALKS 9072, High Dose (Drug)
结局指标
主要结局
Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 12 months
This measure includes all incidences, including those that occurred \>5%.
次要结局
- Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time(Up to 12 months)
- Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time(Up to 12 months)
研究者
研究点 (2)
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