Phase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine (RP5063) in Subjects with an Acute Exacerbation of Schizophrenia, Followed by a 52-Week Open-label Extension
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 402
- 试验地点
- 12
- 主要终点
- 1) Double Blind Safety and Efficacy of RP5063 (brilaroxazine)
研究概览
简要总结
This is a randomized, DoubleBlind (DB), placebo-controlled, multicenter study to assess the efficacy andsafety of RP5063 (brilaroxazine) at fixed doses of 15 mg or 50 mg, administeredOnce Daily (OD) for 28 days (28 days DB treatment) in subjects with an acuteexacerbation of schizophrenia. The study further will assess the safety ofRP5063 (brilaroxazine) at flexible doses of either 15 or 30 or 50 mgadministered OD in an Open Label (OL) treatment over a period of 52 weeks(52-week OL treatment part), in subjects with stable schizophrenia. The OLtreatment will have 2 populations of stable schizophrenia: DB rollover and denovo subjects.
The study comprises 2 parts: a 28days DB treatment; followed by 52 weeks OL treatment.
The total duration of the study is 56 weeks (28days/4 weeks DB treatment and 52-weeks OL treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject is male or female, aged 18 to 65 years 2) Subject reads, understands, and signs an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved current ICF prior to performing any of the Screening procedures 3) Diagnosis schizophrenia.
排除标准
- •Has a history of treatment resistance exhibited by any of the following: a) No or minimal response to at least 2 periods of treatment lasting 28 days or longer, with antipsychotic agents at the maximally tolerated dose.
- •b) Lifetime history of clozapine use c) History of electroconvulsive therapy (ECT) for treatment of schizophrenia within the past 5 years.
- •Is treatment-naïve for schizophrenia.
- •Primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment.
- •Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse disorder.
- •Has a history of the following (a) traumatic brain injury causing ongoing cognitive difficulties, Alzheimers disease, or another form of dementia, or any chronic organic disease of the central nervous system (CNS) (b) intellectual disability of a severity that would impact ability to participate in the study.
- •Subject has a current primary DSM-5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, post-traumatic stress disorder, obsessive-compulsive disorder, manic episode, hypomania, panic disorder, delirium, amnestic or other cognitive disorders.
- •Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
- •On antipsychotic within the Screening Period (minimum 3 days prior to Baseline and throughout the study).
- •Within 28 days prior to Baseline: monoamine oxidase inhibitors, CNS stimulants, potent CYP3A4 or 5 enzyme-inducing drugs including but not limited to rifampin and carbamazepine and strong CYP3A4 or 5 inhibitors like ketoconazole, itraconazole, clarithromycin, etc.
- •Antipsychotic depot medication within 5 half-lives prior to Baseline.
- •Positive Urine Drug Screen for drugs of abuse, including amphetamines, barbiturates, cocaine, ecstasy, phencyclidine or opiates meeting criteria of moderate-to-severe DSM-5 substance use disorder.
结局指标
主要结局
1) Double Blind Safety and Efficacy of RP5063 (brilaroxazine)
时间窗: 1) Time Frame: 28 days | 2) Time Frame: 52 weeks
Decrease in Positive and Negative Symptoms Assessment (PANSS) total score compared to placebo from Baseline to Day 28
时间窗: 1) Time Frame: 28 days | 2) Time Frame: 52 weeks
2) Open label Safety and Efficacy of RP5063 (brilaroxazine)
时间窗: 1) Time Frame: 28 days | 2) Time Frame: 52 weeks
RP5063 tablets (at flexible doses of 15 mg or 30 mg or 50mg OD) in an treatment part over a period of 52 weeks in stable schizophrenia subjects. The endpoints would be incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
时间窗: 1) Time Frame: 28 days | 2) Time Frame: 52 weeks
次要结局
- CGI-S scale: Proportion of subjects with greater than or equals to 1-point improvement from Baseline to Day 28.(Baseline to Day 28)