Safety & Efficacy of TC-5619 in Adults With Inattentive-predominant Attention Deficit/Hyperactivity Disorder (ADHD)

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.

Inclusion criteria

• 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

Exclusion criteria

• 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 1. 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