An Open Label, Single Arm, Extension Trial to Examine Long-term Safety of Iclepertin Once Daily in Patients With Schizophrenia Who Have Completed Previous Iclepertin Phase III Trials (CONNEX-X)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,362
- 试验地点
- 303
- 主要终点
- Occurrence of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This study is open to adults with schizophrenia who took part in a previous CONNEX study (study 1346-0011, 1346-0012, or 1346-0013). The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called Iclepertin in the long term.
Participants take Iclepertin as tablets once a day for 1 year. In addition, all participants take their normal medication for schizophrenia.
Participants are in the study for a little more than 1 year. During this time, they visit the study site about 13 times and get about 9 phone calls from the study team.
The doctors collect information on any health problems of the participants. Doctors also regularly check the participants' symptoms of schizophrenia.
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 51 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients with cognitive impairment due to schizophrenia
干预措施: BI 425809 (Drug)
结局指标
主要结局
Occurrence of treatment emergent adverse events (TEAEs)
时间窗: up to 1 year and 12 days
次要结局
- Change from baseline in Haemoglobin (Hb) to EOT(up to 1 year)
- Change from baseline in Clinical Global Impressions - Severity (CGI-S) to end of treatment (EOT)(up to 1 year)