NCT00640419
Completed
Phase 2
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of 0.7 mg/kg/Day and 1.4 mg/kg/Day of ABT-089 in the Treatment of Children With Attention Deficit-Hyperactivity Disorder (ADHD)
Overview
- Phase
- Phase 2
- Intervention
- ABT-089
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 121
- Locations
- 13
- Primary Endpoint
- ADHD-RS-IV (HV)
- 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 (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).
- •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.
Arms & Interventions
1
Intervention: ABT-089
2
Intervention: ABT-089
3
Intervention: placebo
Outcomes
Primary Outcomes
ADHD-RS-IV (HV)
Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42
Secondary Outcomes
- 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)
Study Sites (13)
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