Open-Label Extension Study to Evaluate the Safety of Molindone Hydrochloride Extended-Release Tablets as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 主要终点
- Long Term Safety and tolerability of repeated oral dosing of 810M as an adjunctive therapy in children exhibiting impulsive aggression comorbid w/ ADHD
研究概览
简要总结
Open-label, extension study for subjects that completed 810P202 to examine long term safety and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Successful completion of the 810P202 study.
- •Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
- •Weight of at least 20kg.
- •Able and willing to swallow tablets whole and not chewed, cut or crushed.
- •Written informed consent/assent obtained from the subject's parent or legally-authorized representative (LAR), and written informed assent obtained from the subject if required.
排除标准
- •Body Mass Index (BMI) in 97th percentile or above.
- •Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
- •Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential).
- •Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or complying with the study procedures.
研究组 & 干预措施
Molindone
Extension study, all subjects will be given Molindone at different (established) dosage levels based on the patient's weight, response and investigator discretion.
干预措施: Molindone (Drug)
结局指标
主要结局
Long Term Safety and tolerability of repeated oral dosing of 810M as an adjunctive therapy in children exhibiting impulsive aggression comorbid w/ ADHD
时间窗: over 6 months
Safety Assessments include: Adverse Events, clinical lab tests, vital signs, physical examinations, ECGs, Simpson-Angus Scale, Barnes Akathisia Scale, Abnormal Involuntary Movement Scale (AIMS) and Columbia Suicise Severity Rating Scale (C-SSRS)
次要结局
- Assess the efficacy of 810M(over 6 months)