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

Phase 2

Completed

• Conditions: Attention-Deficit/Hyperactivity Disorder
• Interventions: Drug: ABT-089; Drug: atomoxetine; Drug: placebo

• Registration Number: NCT00528697
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-11
• Study First Submitted QC: 2007-09-11
• Study First Posted: 2007-09-12
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Disposition First Submitted: 2011-08-18
• Disposition First Submitted QC: 2011-08-18
• Disposition First Posted: 2011-08-23
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-21
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ABT-089	Lowest ABT-089 dose
2	ABT-089	Low-medium ABT-089 dose
5	atomoxetine	atomoxetine
6	placebo	placebo
3	ABT-089	Medium-high ABT-089 dose
4	ABT-089	Highest ABT-089 dose

Primary Outcome Measures

Name	Time	Method
ADHD-RS-IV (HV) - Administered by study doctor	Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (20)

Site Reference ID/Investigator# 5982; 🇺🇸 Overland Park, Kansas, United States

Site Reference ID/Investigator# 5981; 🇺🇸 Northbrook, Illinois, United States

Site Reference ID/Investigator# 5996; 🇺🇸 Eugene, Oregon, United States

Site Reference ID/Investigator# 5980; 🇺🇸 Salem, Oregon, United States

Site Reference ID/Investigator# 5999; 🇺🇸 Little Rock, Arkansas, United States

Site Reference ID/Investigator# 5987; 🇺🇸 Clementon, New Jersey, United States

Site Reference ID/Investigator# 5993; 🇺🇸 Bradenton, Florida, United States

Site Reference ID/Investigator# 5992; 🇺🇸 Omaha, Nebraska, United States

Site Reference ID/Investigator# 5977; 🇺🇸 Orlando, Florida, United States

Site Reference ID/Investigator# 5976; 🇺🇸 Memphis, Tennessee, United States

Site Reference ID/Investigator# 5998; 🇺🇸 Herndon, Virginia, United States

Site Reference ID/Investigator# 5984; 🇺🇸 Portland, Oregon, United States

Site Reference ID/Investigator# 5995; 🇺🇸 Jacksonville, Florida, United States

Site Reference ID/Investigator# 5979; 🇺🇸 El Centro, California, United States

Site Reference ID/Investigator# 5986; 🇺🇸 Boulder, Colorado, United States

Site Reference ID/Investigator# 5997; 🇺🇸 Las Vegas, Nevada, United States

Site Reference ID/Investigator# 5983; 🇺🇸 Middleton, Wisconsin, United States

Site Reference ID/Investigator# 5978; 🇺🇸 Bellevue, Washington, United States

Site Reference ID/Investigator# 5994; 🇺🇸 Charleston, South Carolina, United States

Site Reference ID/Investigator# 6000; 🇺🇸 Austin, Texas, United States