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临床试验/NCT04143217
NCT04143217已完成3 期

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With Attention-Deficit/Hyperactivity Disorder

Supernus Pharmaceuticals, Inc.36 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2020年1月23日最近更新:
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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
159
试验地点
36
主要终点
Incidence of Adverse Events
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Open label, flexible dose, long-term multicenter study of safety and efficacy of SPN-812 in adult ADHD patients

详细描述

This is a multicenter, open-label extension study aimed to assess long-term safety and efficacy of SPN-812 when administered alone or in conjunction with an Food and Drug Administration (FDA)-approved Attention-Deficit Hyperactivity Disorder (ADHD) medication in the treatment of ADHD in adult subjects who completed a blinded study of SPN-812 (812P306). Subjects initiate SPN-812 dosing at 200 mg/day once daily (QD) during first 2 weeks. At or after Visit 2 (Week 2), per the Investigator's discretion and based on Investigator's assessment of subject's clinical response and tolerability, the dose of SPN-812 can be titrated up or tapered down in increments of 50 mg/day, 100 mg/day, 150 mg/day, or 200 mg/day per week to a target dose within the ranges between 200 and 600 mg/day. Additionally, after 12 weeks of dosing (after Visit 4), at the discretion of the Investigator and based on subject's clinical response, the optimized dose of SPN-812 may be supplemented with an adjunctive FDA-approved stimulant treatment. Total treatment duration per subject from Visit 1 to Visit 22 (end of study) is approximately 3 years (156 weeks ± 1 week) or until SPN-812 becomes commercially available.

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

盲法说明

None (Open Label)

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Open-Label Treatment

Experimental

SPN-812 Open-Label Treatment 200mg to 600mg SPN-812 once daily for up to 156 weeks

干预措施: SPN-812 (Drug)

结局指标

主要结局

Incidence of Adverse Events

时间窗: Up to 156 weeks

The percent of subjects who took at least one dose of SPN-812 (Safety Population; N) and who reported at least one Adverse Event (n). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and multiplying the product by 100. The higher the percentage, the higher the incidence in the Safety Population

次要结局

  • The Effect of SPN-812 on Overall ADHD Symptoms as Measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on Overall Executive Function in Adults With ADHD as Measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on Behavior Regulation in Adults With ADHD as Measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • The Effect of SPN-812 on Global Assessment of Improvement of ADHD Symptoms as Measured by the Clinical Global Impression - Improvement Scale (CGI-I) Scale(Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on Metacognition in Adults With ADHD as Measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • The Effect of SPN-812 on Global Assessment of ADHD Symptom Severity as Measured by the Clinical Global Impression - Severity of Illness (CGI-S)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • The Effect of SPN-812 on Clinical Global Impression - Severity of Illness (CGI-S) Responder Rate(Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • The Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Responder Rate(Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on Symptoms of Anxiety as Measured by the Generalized Anxiety Disorder 7-Item (GAD-7) Scale(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on Inattention (IA) Symptoms as Measured by the Adult ADHD Investigator Symptom Rating IA Subscale(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on the 50% Adult ADHD Investigator Symptom Rating Scale (AISRS) Responder Rate(Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on the 30% Adult ADHD Investigator Symptom Rating Scale (AISRS) Responder Rate(Weeks 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on the "Shift" Scale in Adults With ADHD as Measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on Hyperactivity/Impulsivity (H/I) Symptoms as Measured by the Adult ADHD Investigator Symptom Rating H/I Subscale(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on the "Inhibit" Scale in Adults With ADHD as Measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on the "Working Memory" Scale in Adults With ADHD as Measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on the "Initiate" Scale in Adults With ADHD as Measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on "Organization of Materials" Scale in Adults With ADHD as Measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on Overall Symptoms of Depression in Adults With ADHD as Measured by the Symptoms of Depression Questionnaire (SDQ)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effects of SPN-812 on "Life Outlook" Aspect of Quality of Life in Adults With ADHD as Measured by the Adult ADHD Quality of Life Scale (AAQoL)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on the "Self-Monitor" Scale in Adults With ADHD as Measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on the "Emotional Control" Scale in Adults With ADHD as Measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on "Lassitude, Mood, and Cognitive Functioning" (SDQ-1) Subscale in Adults With ADHD as Measured by the Symptoms of Depression Questionnaire (SDQ)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effects of SPN-812 on "Life Productivity" Aspect of Quality of Life in Adults With ADHD as Measured by the Adult ADHD Quality of Life Scale (AAQoL)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on the "Plan/Organize" Scale in Adults With ADHD as Measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on the "Task Monitor" Scale in Adults With ADHD as Measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A; Self Report)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on Overall Quality of Life in Adults With ADHD as Measured by the Adult ADHD Quality of Life Scale (AAQoL)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effects of SPN-812 on "Relationships" Aspect of Quality of Life in Adults With ADHD as Measured by the Adult ADHD Quality of Life Scale (AAQoL)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on "Anxiety, Agitation, Irritability, and Anger" (SDQ-2) Subscale in Adults With ADHD as Measured by the Symptoms of Depression Questionnaire (SDQ)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on "Suicidal Ideation" (SDQ-3) Subscale in Adults With ADHD as Measured by the Symptoms of Depression Questionnaire (SDQ)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on "Disruptions in Sleep Quality" (SDQ-4) Subscale in Adults With ADHD as Measured by the Symptoms of Depression Questionnaire (SDQ)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effect of SPN-812 on "Appetite and Weight" (SDQ-5) Subscale in Adults With ADHD as Measured by the Symptoms of Depression Questionnaire (SDQ)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)
  • Effects of SPN-812 on "Psychological Health" Aspect of Quality of Life in Adults With ADHD as Measured by the Adult ADHD Quality of Life Scale (AAQoL)(Baseline and Week 2, 4, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 108, 116, and 124)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (36)

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