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ABT-089

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment141

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

ABT-089 is an investigational small molecule being studied for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and children. It is in Phase 2 clinical development and has not been approved by the FDA. The drug is being developed by AbbVie Inc.

Who makes ABT-089?

ABT-089 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is an investigational small molecule in Phase 2 clinical trials for Attention-Deficit/Hyperactivity Disorder (ADHD).

What phase is ABT-089 in?

ABT-089 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. All four completed clinical trials for ABT-089 were Phase 2 studies, with no active trials currently ongoing.

What clinical trials is ABT-089 in?

ABT-089 has completed four Phase 2 clinical trials in the United States. These include NCT00443391 and NCT00640185 in adults with ADHD, NCT00640419 in children with ADHD, and NCT00686933, a long-term safety study in adults. All trials are completed with a total enrollment of 676 participants.

Is ABT-089 the same as any other drug?

ABT-089 is the primary name for this investigational drug. No alternative names have been reported in clinical trial records. It is a small molecule being studied for Attention-Deficit/Hyperactivity Disorder (ADHD) and is not the same as other marketed ADHD medications.