A Safety and Efficacy 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; Drug: atomoxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528697

M06-888

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 or ADHD.

Enrollment: 278 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)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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278 participants in 6 patient groups, including a placebo group

1

Experimental group

Description:

Lowest ABT-089 dose

Treatment:

Drug: ABT-089

2

Experimental group

Description:

Low-medium ABT-089 dose

Treatment:

Drug: ABT-089

3

Experimental group

Description:

Medium-high ABT-089 dose

Treatment:

Drug: ABT-089

4

Experimental group

Description:

Highest ABT-089 dose

Treatment:

Drug: ABT-089

5

Active Comparator group

Description:

atomoxetine

Treatment:

Drug: atomoxetine

6

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo