CompletedNCT00528697Updated Jan 29, 2013

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

A Phase 2 interventional study of ABT-089 and atomoxetine in Attention-Deficit/Hyperactivity Disorder, sponsored by AbbVie (prior sponsor, Abbott). Completed at 20 sites in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2013-01-29.

Sponsored by AbbVie (prior sponsor, Abbott) · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 278
Allocation: Randomized
Ages: 6 Years to 12 Years
Sex: All

Study 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.

Conditions studied

Attention-Deficit/Hyperactivity Disorder

Browse trials for

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 278 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 12 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 278 participants (actual)

Study arms

Experimental
1
Lowest ABT-089 dose
Drug: ABT-089
Experimental
2
Low-medium ABT-089 dose
Drug: ABT-089
Experimental
3
Medium-high ABT-089 dose
Drug: ABT-089
Experimental
4
Highest ABT-089 dose
Drug: ABT-089
Active comparator
5
atomoxetine
Drug: atomoxetine
Placebo comparator
6
placebo
Drug: placebo

Interventions

DrugABT-089
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.
Drugatomoxetine
Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
Drugplacebo
Subject will take a tablet once daily for 8 weeks

What researchers measure

Primary outcomes

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

Secondary outcomes

Health Outcomes Measurements
Time frame: Baseline to Final Evaluation of 8-week treatment period
Clinical Global Impression-ADHD-Severity Scale
Time frame: Baseline to Final Evaluation of 8-week treatment period
Parent Rating Scales
Time frame: Baseline to Final Evaluation of 8-week treatment period
Teacher Rating Scale
Time frame: Baseline to Final Evaluation of 8-week treatment period

Study locations

20 sites

Site Reference ID/Investigator# 5999
Little Rock, Arkansas 72205, United States
Site Reference ID/Investigator# 5979
El Centro, California 92243, United States
Site Reference ID/Investigator# 5986
Boulder, Colorado 80304, United States
Site Reference ID/Investigator# 5993
Bradenton, Florida 34208, United States
Site Reference ID/Investigator# 5995
Jacksonville, Florida 32216, United States
Site Reference ID/Investigator# 5977
Orlando, Florida 32806, United States
Site Reference ID/Investigator# 5981
Northbrook, Illinois 60062, United States
Site Reference ID/Investigator# 5982
Overland Park, Kansas 66212, United States
Site Reference ID/Investigator# 5992
Omaha, Nebraska 68198, United States
Site Reference ID/Investigator# 5997
Las Vegas, Nevada 89128, United States
Site Reference ID/Investigator# 5987
Clementon, New Jersey 08021, United States
Site Reference ID/Investigator# 5996
Eugene, Oregon 97401, United States
Site Reference ID/Investigator# 5984
Portland, Oregon 97210, United States
Site Reference ID/Investigator# 5980
Salem, Oregon 97301, United States
Site Reference ID/Investigator# 5994
Charleston, South Carolina 29405, United States
Site Reference ID/Investigator# 5976
Memphis, Tennessee 38119, United States
Site Reference ID/Investigator# 6000
Austin, Texas 78756, United States
Site Reference ID/Investigator# 5998
Herndon, Virginia 20170, United States
Site Reference ID/Investigator# 5978
Bellevue, Washington 98007, United States
Site Reference ID/Investigator# 5983
Middleton, Wisconsin 53562, United States

References and documents

Publications

Wilens TE, Gault LM, Childress A, Kratochvil CJ, Bensman L, Hall CM, Olson E, Robieson WZ, Garimella TS, Abi-Saab WM, Apostol G, Saltarelli MD. Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):73-84.e1. doi: 10.1016/j.jaac.2010.10.001. Epub 2010 Nov 25. PubMed 21156272 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00528697
Lead sponsor: AbbVie (prior sponsor, Abbott)
Responsible party: Sponsor
First posted: Sep 12, 2007
Start date: Sep 2007
Primary completion: Apr 2008
Completion: Apr 2008
Last update: Jan 29, 2013

Study contacts

Laura Gault, MD, PhD, MD

study director · AbbVie

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hyperkinesis→

Other studies from this sponsor

AbbVie (prior sponsor, Abbott)

Start the discussion