NCT05182476终止2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Subjects With Cognitive Impairment Associated With Schizophrenia, Followed by Open-Label Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score
研究概览
简要总结
Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.
详细描述
A Phase 2, randomized, double-blind, parallel, placebo-controlled study with a 6- or 12-month open-label extension. The study is designed to evaluate the efficacy, safety and tolerability, and pharmacokinetics (PK) of treatment with luvadaxistat when administered orally once daily as an adjunctive treatment on improving symptoms of cognitive impairment associated with schizophrenia (CIAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following inclusion criteria:
- •Completed written informed consent.
- •Participant must be 18 to 50 years of age (inclusive) and able to comply with all protocol procedures.
- •Diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- •The initial diagnosis of schizophrenia must be ≥1 year before screening.
- •The participant is currently receiving a stable regimen of psychotropic medications.
- •Participant has stable symptomatology ≥3 months before the screening visit.
- •The participant must have an adult informant.
- •A body weight of at least 45 kilograms (kg) and a body mass index (BMI) of 18.0 to 45.0 kg/meter squared (m^2), inclusive.
- •Key Exclusion Criteria
- •Participants will be excluded from the study if they meet any of the following criteria:
- •Pregnant or breastfeeding or plans to become pregnant during the study.
- •Exhibit more than a minimal level of extrapyramidal signs/symptoms.
- •Schizophrenia diagnosis occurred before 12 years of age.
- •Lifetime diagnosis of schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder.
- •Recent occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions.
- •Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within 6 months before screening.
- •Diagnosis of moderate or severe substance use disorder (with the exception of nicotine dependence) within 12 months prior to screening.
- •Positive drug screen for disallowed substances.
- •Any other medical or psychiatric condition or cognitive impairment that may interfere with study conduct or clinical assessments.
排除标准
- 未提供
研究组 & 干预措施
Luvadaxistat treatment schedule 1
Experimental
Luvadaxistat daily
干预措施: Luvadaxistat (Drug)
Placebo
Placebo Comparator
Placebo daily
干预措施: Placebo (Drug)
Luvadaxistat treatment schedule 2
Experimental
Luvadaxistat daily
干预措施: Luvadaxistat (Drug)
结局指标
主要结局
Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score
时间窗: Baseline, Day 98
次要结局
- Change From Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Score(Baseline, Day 98)
- Change From Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)(Baseline, Day 98)
- Change From Baseline on the Clinical Global Impression-Severity Scale (CGI-S) Score(Baseline, Day 98)
研究者
研究点 (1)
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