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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 12
- 主要终点
- To evaluate the long-term safety and tolerability of evenamide given orally in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their current antipsychotic medication.
研究概览
简要总结
This is a 46-week, open-label, multi-center, extension to Study NW-3509/014/II/2019 (Study 014) designed to evaluate the long-term safety, tolerability and preliminary efficacy of evenamide as add-on treatment in patients with TRS on a stable therapeutic dose of an antipsychotic. In Study 014, 50 patients are to be randomized equally (1:1) to the 7.5 mg bid and 15 mg bid doses (approximately 25 in each group), and key safety data from these patients will be reviewed by an Independent Safety Monitoring Board (ISMB). If this review of the data indicates there are no safety issues, the 30 mg bid dose group will be initiated, and randomization will continue, with a total of approximately 50 patients being enrolled in each of the three treatment groups. If the 30 mg bid group is not added, the 150 patients will be randomly assigned (1:1) to the 7.5 and 15 mg bid treatment groups (approximately 75 in each group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients must meet the following inclusion criteria to be eligible for enrollment into the study:
- •Patient completed 6 weeks of treatment in Study
- •Patient has provided written informed consent for this extension study.
- •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
- •The presence of any of the following will exclude a patient from study enrollment:
- •Patient violated any requirement of the protocol in Study 014 that would put him/her at risk for continuing treatment with evenamide in Study
- •In the Investigator’s opinion, the patient had a significant worsening of risk for suicidality during Study
- •Patient is experiencing any moderate/severe neurological side effects, other than pre-existing EPS related to antipsychotic treatment prior to enrolling in Study
- •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.
- •Patient demonstrated substantial non-compliance with dosing of the study medication in Study 014.
结局指标
主要结局
To evaluate the long-term safety and tolerability of evenamide given orally in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their current antipsychotic medication.
时间窗: 46 weeks
次要结局
- To evaluate preliminary long-term efficacy of evenamide, based on symptoms of schizophrenia, as assessed by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression - Change from baseline (CGI-C) and Severity of illness (CGI-S);(• To determine the long-term effect of evenamide on daily functioning, based on changes on the Strauss-Carpenter Level of Functioning (LOF) scale.)