Safety and Tolerability 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: placebo

• Registration Number: NCT00640419
• 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 (ADHD).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-21
• Primary Completion: 2008-07
• Study Completion: 2008-07
• 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: 2013-01-10
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ABT-089	-
2	ABT-089	-
3	placebo	-

Primary Outcome Measures

Name	Time	Method
ADHD-RS-IV (HV)	Screening, Day -1, Day 7, Day 14, Day 28, Day 42

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Site Reference ID/Investigator# 7536; 🇺🇸 Little Rock, Arkansas, United States

Site Reference ID/Investigator# 7954; 🇺🇸 Bradenton, Florida, United States

Site Reference ID/Investigator# 7559; 🇺🇸 Omaha, Nebraska, United States

Site Reference ID/Investigator# 7564; 🇺🇸 Oklahoma City, Oklahoma, United States

Site Reference ID/Investigator# 7560; 🇺🇸 Troy, Michigan, United States

Site Reference ID/Investigator# 7540; 🇺🇸 Memphis, Tennessee, United States

Site Reference ID/Investigator# 7543; 🇺🇸 Jacksonville, Florida, United States

Site Reference ID/Investigator# 7538; 🇺🇸 Portland, Oregon, United States

Site Reference ID/Investigator# 7544; 🇺🇸 Bellevue, Washington, United States

Site Reference ID/Investigator# 7537; 🇺🇸 Libertyville, Illinois, United States

Site Reference ID/Investigator# 7542; 🇺🇸 Orlando, Florida, United States

Site Reference ID/Investigator# 7561; 🇺🇸 Overland Park, Kansas, United States

Site Reference ID/Investigator# 7541; 🇺🇸 Las Vegas, Nevada, United States