EUCTR2020-000439-32-IT进行中（未招募）1 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. - NW-3509/015/II/2019
EWRON PHARMACEUTICALS SPA0 个研究点目标入组 150 人开始时间: 2020年10月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet the following inclusion criteria to be eligible for enrollment into the study:
- •1. Patient completed 6 weeks of treatment in Study 014.
- •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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 143
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •The presence of any of the following will exclude a patient from study enrollment:
- •1. Patient violated any requirement of the protocol in Study 014 that would put him/her at risk for continuing treatment with evenamide in Study 015.
- •2. In the Investigator’s opinion, the patient had a significant worsening of risk for suicidality during Study 014.
- •3. Patient is experiencing any moderate/severe neurological side effects, other than pre-existing EPS related to antipsychotic treatment prior to enrolling in Study 014.
- •4. Patient has shown significant worsening of his/her symptoms of schizophrenia between baseline and the final assessment during the 6-week treatment period in Study 014, such that continuing treatment in Study 015 is considered undesirable.
- •5. Patient demonstrated substantial non-compliance with dosing of the study medication in Study 014.
研究者
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