CTIS2024-511560-93-00进行中（未招募）1 期
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) - 1346-0014
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,479
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)), Patients, who completed 26 weeks of treatment in the parent trial, must enter the extension trial: - Within 2 weeks the end of treatment visit in 1346-0011, 1346-0013 (i.e. Follow Up 1 timepoint including the applicable time windows). - At the end of safety follow up in 1346-0012 (within 7 days of visit Follow Up 6)., Have a study partner, defined as any person capable of understanding trial related procedures, with a minimum of 8th grade level of education, who knows the patient well, has been capable of interacting with the patient on a regular basis. Preferably be the same person throughout the study., Further inclusion criteria apply.
排除标准
- •Participant who developed DSM-5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial, Any suicidal behavior and/ or suicidal ideation of type 5 based on the C-SSRS in parent trial and up to and including Visit 1 of this study., Patients diagnosed with moderate or severe substance use disorder, Haemoglobin- Hb drop below 100g/L (10g/dL) OR Hb decrease of 25% or more from baseline and is below lower limit of normal in parent trial (alert 3 from last measure Hb in parental trial), Patients who have been diagnosed with hemoglobinopathies during the parent trial., Further exclusion criteria apply.
研究者
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