A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Fixed Dose Study to Assess Efficacy, Safety, and Tolerability of TC-5619 in Adults With Inattentive-Predominant Attention Deficit/Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 12
- 主要终点
- Inattentive Subscale of the Conner's Adult ADHD-Investigator Version (CAARS-INV)
研究概览
简要总结
Study is to assess if TC-5619 improves symptoms for adults diagnosed with the inattentive-predominant subtype of ADHD over a 4-week treatment period.
详细描述
A 3-arm, double-blind, randomized, placebo-controlled, multicenter, fixed dose study to assess efficacy and safety of TC-5619 in adults with inattentive-predominant attention deficit/hyperactivity disorder (ADHD) utilizing the Connor's Adult ADHD Rating Scale-Investigator Completed Version (CAARS-INV) inattentive subscale scores through 4 weeks of treatment.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Inattentive predominant ADHD per DSM-IV TR) criteria at Screening
- •Score ≥ 2 on at least 6 of 9 items in the inattentive subscale of the CAARS-INV at Baseline (Day 1)
- •Score of < 2 on at least 4 of 9 items in the hyperactive/impulsivity subscale of the CAARS-INV at Baseline (Day 1)
- •Score ≥ 4 (at least moderate) on the CGI-S
- •Tobacco non-users as indicated by lack of tobacco use within the last 6 months prior to Screening, and by negative urinary cotinine level of < 50 ng/mL after quantification
排除标准
- •Current DSM-IV Axis I psychiatric disorder other than ADHD;
- •Use of tobacco cessation agents within 4 weeks prior to Screening
- •Known or suspected drug abuse within the last 6 months prior to Screening
- •Urine drug screen positive for illegal or non-prescribed drugs at Screening
- •Patients at imminent risk of suicide or of danger to themselves or others as judged by the investigator
- •Use of drugs affecting cognitive function within 4 weeks prior to Day
- •This includes use of any concomitant medications for treatment of ADHD.
- •History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular (CV), gastrointestinal (GI), or urological disorder; or diagnosis of major depressive disorder
- •Myocardial infarction within past year
- •Seizure disorder within past year
- •Type 1 diabetes mellitus (DM); type 2 DM that requires medication (diet-controlled allowed)
- •HbA1C > 7.4 at Screening
- •BMI < 15 or > 35; male weight < 100 lbs; female weight < 80 lbs.
- •Current tuberculosis (TB) or known systemic infection [Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)]
- •Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control
- •Participation in another Central Nervous System (CNS)-related clinical trial in the last 3 months and any other clinical trial in last 30 days prior to Screening, or participation in a previous TC-5619 clinical trial
研究组 & 干预措施
TC-5619-238 (25mg)
TC-5619-238 25 mg will be provided as hard gelatin capsules
干预措施: TC-5619-238 25mg (Drug)
Placebo
Placebo will be provided as hard gelatin capsules similar to TC-5619-238
干预措施: Placebo (Drug)
TC-5619-238 (5 mg)
TC-5619-238 5 mg will be provided as hard gelatin capsules.
干预措施: TC-5619-238 5mg (Drug)
结局指标
主要结局
Inattentive Subscale of the Conner's Adult ADHD-Investigator Version (CAARS-INV)
时间窗: 4 weeks
Scores on the inattentive subscale of the CAARS-INV obtained at Day 1 (baseline) and weeks 2, 4, and 6. Primary comparison will be difference between Day 1 and Week 4 (TC-5619 5mg and 25 mg vs. placebo).
次要结局
- Conner's Adult ADHD-Investigator Version total score(4 weeks)
- Conner's Adult ADHD Rating Scale-Subject Self-Rating Version (CAARS-S)(4 weeks)