A 52 Week, Open Label Safety and Tolerability Study of LB-102 in Adult Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 46
- 主要终点
- Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events.
研究概览
简要总结
Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia
详细描述
Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia who are experiencing inadequate response or who are having issues with side effects, general tolerability, or overall effectiveness of their current antipsychotic medication and desire to change medications, or who have completed their participation in current LB-102 clinical studies
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide ICF
- •Patients clinically stable PANSS </= 80 at screening
- •CGI-S </+ 3 at screening
- •Medically stable
- •BMI 18 -40
- •Taking oral antipsychotic treatment for at least 30 days
- •Have stable living environment
排除标准
- •Sexually active M/F patients not willing to use highly effective contraception
- •Breast feeding
- •History of treatment resistance to schizophrenia medications
- •DSM-5 current diagnosis other than schizophrenia
- •Risk of suicidal behavior
- •History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other
研究组 & 干预措施
LB-102
An open label study
干预措施: LB-102 (Drug)
结局指标
主要结局
Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events.
时间窗: 52 weeks
Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation
次要结局
- Evaluate long term safety and tolerability(52 weeks)
- Assess the long-term effectiveness determined by Positive and Negative Syndrome Scale (PANSS)(52 weeks)