A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents (13-17 Years Old) With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 57
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
详细描述
This is a long-term, multicenter, open-label trial designed to examine the long-term safety and tolerability of brexpiprazole in adolescent participants (ages 13-17) with a DSM-5 diagnosis of schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male & female subjects 13-17 years of age, inclusive.
- •Subjects who turn 18 during trial 331-10-234 are permitted in this trial.
- •Subjects with a current primary diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by the K-SADS-PL completed at time of entry into Trial 331-10-
- •For de novo subjects who did not participate in Trial 331-10-234, the initial diagnosis of schizophrenia must be made and documented, and the diagnosis confirmed by the K-SADS-PL at screening.
- •Subjects who, in the investigator's judgment, require treatment with antipsychotic medication(s).
排除标准
- •Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening
- •Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (e.g., medication, illicit drug use).
- •History of failure of clozapine treatment or response to clozapine treatment only.
- •History of neuroleptic malignant syndrome
研究组 & 干预措施
De Novo (Conversion Period)
1-3 milligrams/day (mg/day) brexpiprazole for 1 to 4 weeks
干预措施: Brexpiprazole (Drug)
Prior Placebo and Current Brexpiprazole (Open-label Treatment Period)
1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
干预措施: Brexpiprazole (Drug)
Prior and Current Brexpiprazole (Open-label Treatment Period)
1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
干预措施: Brexpiprazole (Drug)
Prior Aripiprazole and Current Brexpiprazole (Open-label Treatment Period)
1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
干预措施: Brexpiprazole (Drug)
De Novo (Open-label Treatment Period)
1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
干预措施: Brexpiprazole (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: From the first dose of study drug (including the conversion period and the open-label treatment period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months).
An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment.
Number of Participants With Serious Treatment Emergent Adverse Events (TEAEs)
时间窗: From the first dose of study drug (including the conversion period and the open-label treatment period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months).
An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. A serious adverse event (SAE) is any AE occurring at any dose that results in death, life-threatening experience, persistent or significant disability/incapacity, in-patient hospitalization or prolongs hospitalization or congenital anomaly/birth defect. A serious TEAE is defined as an AE that occurred or worsened after the first dose of study treatment up until 30 days after the last dose.
Number of Participants Who Discontinued the Trial Due to AEs
时间窗: From the first dose of study drug (including the conversion period and the open-label treatment period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months).
An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. Participants who discontinued the trial due to AEs were recorded.
次要结局
- Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Units Per Liter)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Milligrams Per Deciliter)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Percentage)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Million Cells Per Microliter)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Clinical Laboratory Tests (Parameters Assessed in Thousand Cells Per Microliter)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Laboratory Tests (Parameters That Were Unitless)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Nanograms Per Milliliter)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Milliequivalents Per Liter)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Vital Signs (Parameters Assessed in Beats Per Minute)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Vital Signs (Parameters Assessed in Millimeters of Mercury)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Vital Signs (Parameters Assessed in Centimeters)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Vital Signs (Parameters Assessed in Kilograms)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Vital Signs (Parameters Assessed in Celsius)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Vital Signs (Parameters Assessed in Z-Score)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Vital Signs (Parameters Assessed in Kilograms Per Meter Square)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Number of Participants With Clinically Significant Abnormalities in Vital Signs(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in Electrocardiogram (ECG) (Parameters Assessed in Milliseconds)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in ECG Parameters (Parameters Assessed in Beats Per Minute)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Number of Participants With Clinically Significant Abnormalities in ECG Parameters(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline on the Abnormal Involuntary Movement Scale (AIMS) Total Score(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline on the Simpson-Angus Scale (SAS) Total Score(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Change From Baseline in the Barnes Akathisia Rating Scale (BARS) Total Score(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Number of Participants With At Least One Occurrence of Suicidal Behavior or Suicidal Ideation as Recorded on Columbia-Suicide Severity Rating Scale (C-SSRS)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Number of Participants With Psychotropic Side Effects as Assessed by Udvalg for Kliniske Undersogelser (UKU) Rating Scale(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Number of Participants With at Least One Occurrence of Cognitive Adverse Effects Assessed by New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Number of Participants With Stages of Tanner Scale Score at Baseline and Month 24(Baseline, Month 24)
- Change From Baseline in the PANSS Total Score(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Change From Baseline in the PANSS Positive Subscale Scores(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Change From Baseline in the PANSS Negative Subscale Scores(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Clinical Global Impression Severity (CGI-S) Scale Score(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))
- Mean Clinical Global Impression - Improvement (CGI-I) Scale Score(From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24))