NCT03247530已完成3 期
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) 100 and 200 mg Efficacy and Safety in Children With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 477
- 试验地点
- 7
- 主要终点
- Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale, 5th Edition (ADHD-RS-5)
研究概览
简要总结
This study will evaluate the efficacy and safety of low doses of SPN-812 in children 6-11 years of age diagnosed with ADHD.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group study, to assess the efficacy and safety of SPN-812 as monotherapy for the treatment of children 6-11 years old with ADHD.
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 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or female subjects, 6-11 years of age, inclusive.
- •Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- •Attention Deficit/Hyperactivity Disorder Rating Scale-5, Home Version: Child, Investigator Administered and Scored (ADHD-RS-5) score of at least
- •CGI-S score of at least 4 at screening.
- •Weight of at least 20 kg.
- •Free of medication for the treatment of ADHD for at least one week prior to randomization and agreement to remain so throughout the study.
- •Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, vital signs, and electrocardiogram.
- •Written informed consent obtained from the subject's parent or legal representative and informed assent from the subject, if applicable.
- •Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose, throughout the study:
- •simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration
- •surgically sterile male partner
- •simultaneous use of male condom and diaphragm with spermicide
- •established hormonal contraceptive
排除标准
- •Current diagnosis of major psychiatric disorders. Subjects with Major Depressive Disorder are allowed in the study if the subject is free of episodes both currently and for the last six months.
- •Current diagnosis of major neurological disorders. Subjects with seizures or a history of seizure disorder within the immediate family (siblings, parents), or a history of seizure-like events are excluded from the study.
- •Current diagnosis of significant systemic disease.
- •Evidence of suicidality (defined as either active suicidal plan/intent or active suicidal thoughts, or more than one lifetime suicide attempt) within the six months before Screening or at Screening.
- •BMI greater than 95th percentile for the appropriate age and gender.
- •History of an allergic reaction to viloxazine or related drugs.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in this study.
- •Subjects who received any investigational drug within the longer of 30 days or 5 half-lives prior to Day 1 dosing of SM.
- •Any reason, which, in the opinion of the Investigator, would prevent the subject from participating in the study.
- •Positive drug screen at the Screening Visit. A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening; the subject will be required to discontinue the stimulant for the study, beginning at least one week prior to the Baseline Visit.
- •Pregnancy or refusal to practice abstinence or acceptable birth control during the study (for female subjects of childbearing potential).
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo, qd, oral capsule
干预措施: Placebo (Drug)
100mg SPN-812
Experimental
100mg SPN-812, qd, oral capsule
干预措施: 100mg SPN-812 (Drug)
200mg SPN-812
Experimental
200mg SPN-812, qd, oral capsule
干预措施: 200mg SPN-812 (Drug)
结局指标
主要结局
Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale, 5th Edition (ADHD-RS-5)
时间窗: Baseline and Week 6 (End of Study)
The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 6 (End of Study). The ADHD-RS-5 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, 5th Edition (DSM-5) 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 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale(Week 6 (End of Study))
- Effect of SPN-812 Assessed by Conners 3 - Parent Short Form (C3PS)(Baseline and Week 6 (End of Study))
- Effect of SPN-812 Assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)(Baseline and Week 6 (End of Study))
- Effect of SPN-812 Assessed by 50% Responder Rate Per the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)(Week 6 (End of Study))
- Effect of SPN-812 Assessed by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF)(Baseline and Week 6 (End of Study))
- Effect of SPN-812 Assessed by the Hyperactivity/Impulsivity Subscale and the Inattention Subscale of the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)(Baseline and Week 6 (End of Study))
- Effect of SPN-812 Assessed by Conners 3 - Self Report Short Form (C3-SRS)(Baseline and Week 6 (End of Study))
- Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"](Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
研究者
研究点 (7)
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