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ABT-089

Phase 2

Attention Deficit Hyperactivity Disorder | Small molecule | Psychiatry |AbbVie Inc.|Trials Updated: Jan 29, 2013

ABT-089 development status

Highest phase Phase 2
Registered trials 10 across 2 sponsors since Oct 2003

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials5
Total Enrollment817

FDA Designations

No designations recorded

ABT-089 clinical trials

ABT-089 · 5 trials · 2 indications

Phase 2 5
NCT00686933Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity Disorder
COMPLETED117 Analytics
NCT00640185Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity Disorder
COMPLETED160 Analytics
NCT00640419Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity Disorder
COMPLETED121 Analytics
NCT00528697A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity Disorder
COMPLETED278 Analytics
NCT00443391A Safety and Tolerability Study of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity Disorder
COMPLETED141 Analytics
PHASE2COMPLETED
Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Attention-Deficit/Hyperactivity DisorderUnlock trial analytics
PHASE2COMPLETED
Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Attention-Deficit/Hyperactivity DisorderUnlock trial analytics
PHASE2COMPLETED
Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Attention-Deficit/Hyperactivity DisorderUnlock trial analytics
PHASE2COMPLETED
A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Attention-Deficit/Hyperactivity DisorderUnlock trial analytics
PHASE2COMPLETED
A Safety and Tolerability Study of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

CAARS:Inv
Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
CGI-ADHD-S
Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
CAARS: Inv Total Score
Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56
ADHD-RS-IV (HV)
Screening, Day -1, Day 7, Day 14, Day 28, Day 42
ADHD-RS-IV (HV) - Administered by study doctor
Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56

Secondary Endpoints

CAARS:Self
Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
BRIEF-A
Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
AAQOL
Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTALHighest ABT-089 dose
5ACTIVE_COMPARATORatomoxetine
6PLACEBO_COMPARATORplacebo

Interventions

NameTypeDescription
ABT-089DRUGSubjects will take up to 80 mg daily for 24 months
PlaceboDRUGSubjects will take one or two placebos once daily for the duration of the study.
atomoxetineDRUGSubjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * The subject was randomized into Study M10-346 and completed the study. * Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements. * Male subjects must agree to ...

Countries:United States
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Frequently asked questions about ABT-089

What is ABT-089?

ABT-089 is an investigational small molecule developed by AbbVie Inc. for Attention Deficit Hyperactivity Disorder. It has been studied in Phase 2 clinical trials in both adults and children with ADHD. It is not an approved treatment and remains in clinical development.

What is ABT-089 used for in ADHD?

ABT-089 was studied as a potential treatment for Attention Deficit Hyperactivity Disorder in adults and children. Its Phase 2 program evaluated safety, tolerability, and efficacy in these populations. No approved use has been established for ABT-089.

Who makes ABT-089?

ABT-089 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the Phase 2 clinical program evaluating the compound in Attention Deficit Hyperactivity Disorder.

What phase is ABT-089 in?

ABT-089 is in Phase 2 development. Five Phase 2 trials have been completed, and no trials are currently active. The studies enrolled a total of 817 participants with Attention Deficit Hyperactivity Disorder.

What clinical trials is ABT-089 in?

ABT-089 has been evaluated in five completed Phase 2 trials, including NCT00686933, NCT00640419, NCT00640185, and NCT00528697. These studies assessed safety, tolerability, and efficacy in adults and children with Attention Deficit Hyperactivity Disorder, with enrollment ranging from 117 to 278 participants.

How were the ABT-089 trials designed?

The ABT-089 Phase 2 trials were randomized, double-blind, and placebo-controlled. They enrolled 817 participants total across adult and pediatric Attention Deficit Hyperactivity Disorder populations, with studies conducted in the United States. All five trials have been completed.