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ABT-288 Low Dose

Phase 2

Cognitive Deficits in Schizophrenia | Small molecule | Psychiatry |AbbVie Inc.|Last Updated: Jun 6, 2018

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_CONTROLLEDDMC
Total Trials1
Total Enrollment214
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01077700Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With SchizophreniaPHASE2 COMPLETED 214Mar 1, 2010Jul 1, 2011Jun 6, 201824 United States
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Study Endpoints
Primary Endpoints
Cognition: MCCB
Measurements from screening period through 12-week treatment period
Secondary Endpoints
Functioning: UPSA-2
Measurements from screening period through 12-week treatment period
Cognition: CANTAB
Measurements from screening period through 12-week treatment period
Symptom Severity: PANSS, NSA-16, CGI-S
Measurements from screening period through 12-week treatment period
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABT-288 Dose 1EXPERIMENTALlow dose of ABT-288
ABT-288 Dose 2EXPERIMENTALhigh dose of ABT-288
Sugar PillPLACEBO_COMPARATORinactive substance
Interventions
NameTypeDescription
ABT-288 Low DoseDRUG -
PlaceboDRUGinactive substance
ABT-288 High DoseDRUG -
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Eligibility Criteria
Age Range20 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Has current DSM-IV-TR diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview. * Is clinically stable while receiving antipsychotic therapy with one or two atypical antipsychotic medications: lack of hospitalizations from 4 months of Initial S...

Countries:United States
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