NCT01626456已完成3 期
A Phase 3, Multicenter, Extension of Study ALK9072-003 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
- 478
- 试验地点
- 1
- 主要终点
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •(Subjects who participated in ALK9072-003)
- •Completed the ALK9072-003 Day 85 visit
- •Continues to require treatment with an antipsychotic medication
- •(New Subjects)
- •On a stable dose of oral antipsychotic medication
- •Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable
- •Has been able to achieve outpatient status for more than 3 months prior to screening
- •Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
- •Resides in a stable living situation
排除标准
- •(Subjects who participated in ALK9072-003)
- •Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug
- •Missed more than 1 scheduled study visit during participation in study ALK9072-003
- •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 in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures
- •(New Subjects)
- •History of poor or inadequate clinical response to treatment with aripiprazole
- •History of treatment resistance
- •Diagnosis of current substance dependence (including alcohol)
- •Pregnant, lactating, or breastfeeding
- •Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening
- •Currently under involuntary hospitalization
- •Current or expected incarceration
- •Additional inclusion/exclusion criteria may apply
研究组 & 干预措施
ALKS 9072, Low
Experimental
干预措施: ALKS 9072, Low (Drug)
ALKS 9072, High
Experimental
干预措施: ALKS 9072, High (Drug)
结局指标
主要结局
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
时间窗: 52 weeks
This measure includes incidences \>5%.
次要结局
- Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests(52 weeks)
- Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores(52 weeks)
- Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)(52 weeks)
- Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)(52 weeks)
- Discontinuation From Study Due to Adverse Events (AEs)(52 weeks)
研究者
研究点 (1)
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