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

AbbVie

Status and phase

Completed

Phase 2

Conditions

Attention-Deficit/Hyperactivity Disorder

Treatments

Drug: ABT-089

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00640419

M10-345

Details and patient eligibility

About

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).

Enrollment

121 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

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.