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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: TC-5619-238 5mg
* Drug: TC-5619-238 25mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TC-5619-238 (25mg)<br>TC-5619-238 25 mg will be provided as hard gelatin capsules | Drug: TC-5619-238 25mg<br>* TC-5619-238 25mg capsules taken once daily for 4 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo will be provided as hard gelatin capsules similar to TC-5619-238 | Drug: Placebo<br>* Placebo capsules will be taken once daily for 4 weeks<br>|
| Experimental: TC-5619-238 (5 mg)<br>TC-5619-238 5 mg will be provided as hard gelatin capsules. | Drug: TC-5619-238 5mg<br>* TC-5619-238 5mg capsule taken once daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inattentive Subscale of the Conner's Adult ADHD-Investigator Version (CAARS-INV) | 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). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conner's Adult ADHD-Investigator Version total score | Scores on the total 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). | 4 weeks | 
| Conner's Adult ADHD Rating Scale-Subject Self-Rating Version (CAARS-S) | Scores on the CAARS-S 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). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD