A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Overview
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Brief Summary
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The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention-Deficit/Hyperactivity Disorder or ADHD.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Children With Attention Deficit-Hyperactivity Disorder (ADHD)

Conditions
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Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment
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* Drug: ABT-089
* Drug: atomoxetine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have voluntarily signed an informed consent form Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with parent(s) First grade or higher in a school setting 3 days/week Subject is generally in good health based on medical history, physical examination, clinical lab tests, and ECG Subject weighs at least 37 pounds (17 kg) Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements Subject and parents have been judged by the study doctor to be reliable to keep required appointments for clinic visits and all tests, including blood draws, and examinations Exclusion Criteria: Subject is not functioning at an age-appropriate level intellectually Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind Subject has a history of significant allergic reaction to any drug Subject requires ongoing treatment with any psychiatric medication Subject has a serious medical condition, seizure disorder (except febrile seizures as an infant), or history of substance abuse or dependence

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: 1<br>Lowest ABT-089 dose | Drug: ABT-089<br>* Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.<br>|
| Experimental: 2<br>Low-medium ABT-089 dose | Drug: ABT-089<br>* Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.<br>|
| Experimental: 3<br>Medium-high ABT-089 dose | Drug: ABT-089<br>* Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.<br>|
| Experimental: 4<br>Highest ABT-089 dose | Drug: ABT-089<br>* Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.<br>|
| Active Comparator: 5<br>atomoxetine | Drug: atomoxetine<br>* Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.<br>|
| Placebo Comparator: 6<br>placebo | Drug: placebo<br>* Subject will take a tablet once daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD-RS-IV (HV) - Administered by study doctor |  | Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Outcomes Measurements |  | Baseline to Final Evaluation of 8-week treatment period | 
| Clinical Global Impression-ADHD-Severity Scale |  | Baseline to Final Evaluation of 8-week treatment period | 
| Parent Rating Scales |  | Baseline to Final Evaluation of 8-week treatment period | 
| Teacher Rating Scale |  | Baseline to Final Evaluation of 8-week treatment period |