A Randomized, Multicenter, Parallel Group, Dose-Ranging Study to Evaluate the Safety and Tolerability of SPN-810 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and Persistent Serious Conduct Problems
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 9
- 主要终点
- The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score
研究概览
简要总结
The primary objective was to evaluate the safety and tolerability of four doses of SPN-810 in children with ADHD and persistent serious conduct problems.
详细描述
This will be a randomized, multicenter, parallel group, dose-ranging safety and tolerability study in children with ADHD and persistent serious conduct problems. The target subjects are healthy male or female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD with persistent serious conduct problems. To determine eligibility for the study, subjects will undergo an initial screening visit. Seventy-two subjects will be randomized in the study; assuming a 17% dropout rate, it is anticipated that 60 subjects will complete the study. The study will consist of a Screening Period (within 28 days prior to the first dose administration), a Titration Period of 2 to 5 weeks, a Maintenance Period of 6 weeks, and a Safety Follow-up, which will be performed 30 days after the final study visit. The total subject duration in the study will be 16 to 19 weeks depending on the treatment group assignment. The total study duration is anticipated to be 15.5 months. A total of 72 subjects will be randomized based on weight at baseline, to 1 of 4 treatment groups.
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
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy pediatric male or female subjects, age 6 to 12 years.
- •Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
- •NCBRF-TIQ disruptive behavior disorder subscale 27 or greater at baseline; AND a score of 2 or more on at least 1 of the following 3 items of the conduct problem subscale: knowingly destroys property, gets in physical fights, physically attacks people.
- •IQ greater than 71.
排除标准
- •Current or lifetime diagnosis of bipolar disorder, post-traumatic stress disorder, personality disorder, or psychosis not otherwise specified.
- •Currently meeting DSM-IV-TR criteria for major depressive disorder, obsessive compulsive disorder, or pervasive developmental disorder.
- •Any other anxiety disorder as primary diagnosis.
- •Use of anticonvulsants, antidepressants, lithium, carbamazepine, valproic acid, or cholinesterase inhibitors within 2 weeks of baseline.
- •Unstable endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics.
研究组 & 干预措施
Treatment 1
Treatment 1: SPN-810 5mg/day for subjects <30kg and 10mg/day for subjects ≥30kg
干预措施: SPN-810 (Drug)
Treatment 2
Treatment 2: SPN-810 10mg/day for subjects <30kg and 20mg/day for subjects ≥30kg.
干预措施: SPN-810 (Drug)
Treatment 3
Treatment 3: SPN-810 15mg/day for subjects <30kg and 30mg/day for subjects ≥30kg.
干预措施: SPN-810 (Drug)
Treatment 4
Treatment 4: SPN-810 20mg/day for subjects <30kg and 40mg/day for subjects ≥30kg.
干预措施: SPN-810 (Drug)
结局指标
主要结局
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score
时间窗: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
The Nisonger Child Behavior Rating Form (NCBRF) is an instrument designed to assess the behavior of children with intellectual or developmental disabilities. The NCBRF-TIQ is a 66-item behavior rating form designed to assess the behavior of children and adolescents with typical development. The NCBRF is made up of three sections: I, Where raters can identify unusual circumstances that may have affected the youth's behavior; II, where positive behaviors are rated, and III, a listing of problem behaviors. There are separate Teacher and Parent versions of the form, and the NCBRF takes about 15 minutes to complete. The NCBRF is designed to be used with children and adolescents ages 3 to 16 years. The lowest score is a "0" and the highest score is "198". A higher score of the Conduct Problem Subscale score means a worse outcome. A change or negative score means improvement. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).
次要结局
- The Changes From Baseline in the CGI-S(Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks))
- Clinical Global Impression - Improvement Scale (CGI-I)(Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks))
- SNAP-IV ADHD Inattention(Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks))
- SNAP-IV Subscales ADHD Hyperactivity/Impulsivity(Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks))
- SNAP-IV Subscales - ADHD Combined(Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks))