SLCTR/2020/024已完成2 期
An open-label, multi-center, extension study to evaluate the long-term safety, tolerability and preliminary efficacy of evenamide as add-on treatment in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their current antipsychotic medication
Dr Ravi Anand/Newron Pharmaceuticals S.p.A0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
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
入选标准
- •1. Patient completed 6 weeks of treatment in Study NW-3509/014/II/2019
- •2. Patient has provided written informed consent for this extension study.
- •3. If female, patient is not of childbearing potential, pregnant or breastfeeding.
- •For inclusion, female patients must be post-menopausal (age 50 or older with confirmed amenorrhea for >12 months), surgically sterilized, or protected with adequate contraception (barrier method or hormonal contraceptive).
排除标准
- •1) Protocol violation during 014 study.
- •2) Worsening of suicidal risk during 014 study
- •3) Moderate/severe neurological side effects during 014 study
- •4) Worsening of schizophrenia symptoms during study 014
- •5) Non compliance with dosing of study medication during 014
研究者
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