Safety and Tolerability 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 (ADHD).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of 0.7 mg/kg/Day and 1.4 mg/kg/Day of ABT-089 in the Treatment of 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: 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). Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG. Subject weights at least 37 pounds (17 kg) Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements. Subject can swallow pills and subjects and parents are able to keep required appointments for clinic visits and all tests, including blood draws and examinations. Exclusion Criteria: Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger syndrome, pervasive developmental disorder, tics, Tourette syndrome, mental retardation, seizure disorder or traumatic brain injury. Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind. Subject has a history of, or ongoing, serious medical problem. Subject has a history of significant allergic reaction to any drug. Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD. Subject requires ongoing treatment with any psychiatric medication.

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> | Drug: ABT-089<br>* Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.<br>|
| Experimental: 2<br> | Drug: ABT-089<br>* Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.<br>|
| Placebo Comparator: 3<br> | Drug: placebo<br>* Subjects will take placebo capsules and/or tablets (number of capsules or tablets will be based upon weight) once daily for duration of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSHQ |  | Day-1, Day 28, Day 42 | 
| CGI-P |  | Day -1, Day 21, Day 42 | 
| BRIEF |  | Day -1, Day 28, Day 42 | 
| CGI-ADHD-S |  | Screening, Day -1, Day 7, Day 14, Day 28 and Day 42 |