A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB 102 in the Treatment of Adult Patients With Acute Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 456
- 试验地点
- 13
- 主要终点
- Change from baseline to Week 6 on the Positive and Negative Syndrome Scale
研究概览
简要总结
This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, study designed to evaluate the efficacy, safety, tolerability, and of LB-102 versus placebo for the treatment of adult patients with an acute exacerbation of schizophrenia.
详细描述
This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, multicenter study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of LB-102 100 mg once daily (QD) and LB-102 50 mg QD versus placebo QD for the treatment of adult patients with an acute exacerbation of schizophrenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Able to provide ICF
- •Willing to be hospitalized for duration of the study
- •Diagnosis of schizophrenia as defined by DSM-5
- •BMI - 18-40
- •PANSS 80-120
排除标准
- •Sexually active m/f not willing to adhere to highly effect birth control
- •Breast feeding
- •Increase in PANSS of > 20% between screening and baseline
- •History of resistant treatment to schizophrenia medications
- •DSM-5 diagnosis other than schizophrenia
- •Risk of suicidal behavior
- •Risk of violent or destructive behavior
- •Clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 of the AIMS at Screening
- •Score of ≥3 on the BARS global clinical assessment of akathisia at Screening
- •Insulin dependent diabetes
- •Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery
- •History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the patient
研究组 & 干预措施
LB-102 (50 mg tablet)
• LB-102 50 mg given orally for 6 weeks
干预措施: LB-102 (50 mg tablet) (Drug)
LB-102 (100 mg tablet)
LB-102 100 mg given orally for 6 weeks
干预措施: LB-102 (100 mg tablet) (Drug)
Placebo
Placebo given orally for 6 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline to Week 6 on the Positive and Negative Syndrome Scale
时间窗: 6 weeks
Determine whether LB-102, demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo: increase in scale indicates worsening while a decrease in the scale likely indicates a response to treatment
次要结局
- Evaluate the Safety and Tolerability of LB-102(10 weeks)
- Change in Clinical Global Impressions-Severity of Illness scale (CGI-S)(6 weeks)