A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Adult Subjects With Borderline Personality Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity
研究概览
简要总结
This study evaluates the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Participants, who completed the last treatment visit of the previous double-blind brexpiprazole BPD trial and who, in the opinion of the investigator, could potentially benefit from administration of brexpiprazole for the treatment of BPD.
- •Male or female outpatients, ages 18 to 65 years, inclusive, at the time of informed consent of the previous double-blind brexpiprazole BPD trial.
排除标准
- •Sexually active males or females of childbearing potential (FOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. Male participants must also agree not to donate sperm from trial screening/baseline through 30 days after the last dose of investigational medicinal product (IMP).
- •Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
- •Participants who participated in a clinical trial within 90 days prior to screening/baseline (with the exception of a previous brexpiprazole double-blind BPD trial) or who participated in more than 2 clinical trials within a year prior to screening/baseline.
- •Participants who develop a medically significant abnormality.
研究组 & 干预措施
Prior Brexpiprazole 2-3 Milligrams Per Day
Participants who received blinded brexpiprazole 2 to 3 milligrams per day (mg/day) in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
干预措施: Brexpiprazole (Drug)
Prior Placebo
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
干预措施: Brexpiprazole (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity
时间窗: Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered an IMP and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the start of open-label treatment. The severity of AEs was graded on a 3-point scale: 1=Mild (Discomfort noticed, but no disruption to daily activity), 2=Moderate (Discomfort sufficient to reduce or affect normal daily activity), and 3=Severe (Inability to work or perform normal daily activity).
次要结局
- Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities(Screening up to Week 12)
- Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities(Screening up to Week 12)
- Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score(Baseline and Week 12)
- Number of Participants With Potentially Clinically Significant Laboratory Abnormalities(Screening up to Week 12)
- Change From Baseline in Simpson-Angus Scale (SAS) Total Score(Baseline and Week 12)
- Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score(Baseline and Week 12)
- Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline up to Week 12)