NCT03929497终止2 期
Interventional, Open-label, Flexible-dose, Long-term Safety Extension Study of Lu AF11167 in Patients With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 96
- 试验地点
- 30
- 主要终点
- Number of participants with Treatment-Emergent Adverse Events
研究概览
简要总结
A study to evaluate the long-term safety and tolerability of flexible doses of Lu AF11167 in patients with schizophrenia during the 24-week treatment period
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient completed Study 17972A.
- •The patient and the patient's caregiver or identified responsible person is able to read and understand the Informed Consent Form.
- •The patient has signed the Informed Consent Form specific for Study 17972B.
- •The patient can potentially benefit from 24 weeks of treatment with Lu AF11167 according to the investigator's clinical judgment.
排除标准
- •The patient has any current primary psychiatric disorder other than schizophrenia diagnosed during study 17972A
- •The patient, in the opinion of the investigator, is at significant risk of suicide
- •Other in- and exclusion criteria may apply
研究组 & 干预措施
Lu AF11167
Experimental
干预措施: Lu AF11167 (Drug)
结局指标
主要结局
Number of participants with Treatment-Emergent Adverse Events
时间窗: From baseline week 24
Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, BMI, waist, weight, ECG parameters)
次要结局
- Change in PANSS Negative subscale score(from baseline to Week 24)
- Change in Brief Negative Symptom Scale (BNSS) total score(from baseline to Week 24)
- Change in CGI-SCH-S negative symptoms score(from baseline to Week 24)
- Change in Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score(from baseline to Week 24)
- CGI-SCH-DC negative symptoms score(at Week 24)
- CGI-SCH-DC negative symptoms response(at Week 24)
研究者
研究点 (30)
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