Evaluation of the Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD - A Double-Blind, Placebo-Controlled, Dose-Ranging Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV)
研究概览
简要总结
This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.
详细描述
This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV).
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- •ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least
- •CGI-S score of at least 4
- •Weight of at least 20 kg.
- •Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.
排除标准
- •Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
- •Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
- •Significant systemic disease.
- •Evidence of suicidality within the six months before Screening or at Screening.
- •BMI greater than 95th percentile for the appropriate age and gender.
- •Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).
- •Substance or alcohol use during the last three months.
- •Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.
研究组 & 干预措施
Placebo
Placebo, qd, oral capsule
干预措施: Placebo (Drug)
100mg SPN-812
100mg SPN-812, qd, oral capsule
干预措施: 100mg SPN-812 (Drug)
200mg SPN-812
200mg SPN-812, qd, oral capsule
干预措施: 200mg SPN-812 (Drug)
300mg SPN-812
300mg SPN-812, qd, oral capsule
干预措施: 300mg SPN-812 (Drug)
400mg SPN-812
400mg SPN-812, qd, oral capsule
干预措施: 400mg SPN-812 (Drug)
结局指标
主要结局
The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV)
时间窗: Baseline to Week 8 (End of Study)
The Primary Endpoint was the change from baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) Total score at Week 8 (End of Study). The ADHD-RS-IV is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (\<0) represent a better outcome.
次要结局
- Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Scale(Week 8 (End of Study))
- Effect of SPN-812 on the Clinical Global Impression - Severity (CGI-S) Scale(Baseline to Week 8 (End of Study))