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ABT-089

Phase 2

Attention-Deficit/Hyperactivity Disorder | Small molecule | Psychiatry |Abbott Laboratories|Last Updated: Oct 18, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment221

FDA Designations

No designations recorded

Clinical trial landscape

ABT-089 · 1 trial · 1 indication

Phase 2 1
NCT00391729A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity Disorder
COMPLETED221 Analytics
PHASE2COMPLETED
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 DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score
at the final evaluation of each 4-week treatment period

Secondary Endpoints

CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores
at the final evaluation of each 4-week treatment period
CAARS ADHD Index, CAARS:Self
at the final evaluation of each 4-week treatment period
CGI-ADHD-S, AISRS, TASS, FTND
at the final evaluation of each 4-week treatment period
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATOR -
2EXPERIMENTAL -

Interventions

NameTypeDescription
ABT-089DRUGSubjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks
PlaceboDRUGSubjects will take placebo QD, BID for 4-6 weeks
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Meet criteria for attention deficit hyperactivity disorder * Have voluntarily signed an informed consent form * Are between 18 and 60 years of age * Will use contraceptive methods during the study * Women must not be pregnant or breast-feeding * Must be in generally good healt...

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. It is in Phase 2 clinical development and has not been approved by the FDA. One clinical trial has been completed to evaluate its safety and efficacy in this patient population.

Who makes ABT-089?

ABT-089 is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. The drug is an investigational small molecule in Phase 2 clinical development for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults.

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. A Phase 2 clinical trial studying the drug in adults with Attention-Deficit/Hyperactivity Disorder (ADHD) has been completed.

What clinical trials is ABT-089 in?

ABT-089 has one completed clinical trial, identified as NCT00391729. This was a Phase 2, dose-ranging, cross-over study evaluating the safety and efficacy of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (ADHD). The trial enrolled 221 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is ABT-089 FDA approved?

No, ABT-089 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. One clinical trial has been completed, but the drug has not yet received regulatory approval.