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ABT-089

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment221
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00391729A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)PHASE2 COMPLETED 221Oct 1, 2006Jun 1, 2007Oct 18, 201123 United States
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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 — 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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