NCT00528697
Completed
Phase 2
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Children With Attention Deficit-Hyperactivity Disorder (ADHD)
ConditionsAttention-Deficit/Hyperactivity Disorder
Overview
- Phase
- Phase 2
- Intervention
- ABT-089
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 278
- Locations
- 20
- Primary Endpoint
- ADHD-RS-IV (HV) - Administered by study doctor
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Lowest ABT-089 dose
Intervention: ABT-089
2
Low-medium ABT-089 dose
Intervention: ABT-089
3
Medium-high ABT-089 dose
Intervention: ABT-089
4
Highest ABT-089 dose
Intervention: ABT-089
5
atomoxetine
Intervention: atomoxetine
6
placebo
Intervention: placebo
Outcomes
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(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)
Study Sites (20)
Loading locations...
Similar Trials
Completed
Phase 2
Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity DisorderNCT00640419AbbVie (prior sponsor, Abbott)121
Terminated
Phase 2
Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT00555204Abbott337
Completed
Phase 2
Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity DisorderNCT00640185AbbVie (prior sponsor, Abbott)160
Completed
Phase 2
Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT01137526AbbVie (prior sponsor, Abbott)267
Completed
Phase 2
A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity DisorderNCT00391729Abbott221