Recent Updates
Recently added Catalysts

ABT-288 Low Dose

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment214

FDA Designations

No designations recorded

Clinical trial landscape

ABT-288 Low Dose · 1 trial · 1 indication

Phase 2 1
NCT01077700Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With SchizophreniaCognitive Deficits in Schizophrenia
COMPLETED214 Analytics
PHASE2COMPLETED
Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With Schizophrenia
Cognitive Deficits in SchizophreniaUnlock trial analytics

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
Unlock Study Endpoints

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 -
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about ABT-288 Low Dose

What is ABT-288 Low Dose used for?

ABT-288 Low Dose is an investigational small molecule being developed for the treatment of cognitive deficits in schizophrenia. It is intended to address cognitive symptoms associated with the psychiatric condition, which are distinct from the positive symptoms like hallucinations or delusions.

Who makes ABT-288 Low Dose?

ABT-288 Low Dose is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with cognitive deficits in schizophrenia.

What phase is ABT-288 Low Dose in?

ABT-288 Low Dose is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not been approved by regulatory authorities for commercial use.

What clinical trials is ABT-288 Low Dose in?

ABT-288 Low Dose has been studied in one clinical trial, identified as NCT01077700. This Phase 2 study, titled 'Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With Schizophrenia,' was completed and enrolled 214 participants in the United States. The trial was randomized, double-blind, and placebo-controlled.

Is ABT-288 Low Dose FDA approved?

ABT-288 Low Dose is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The completed Phase 2 trial was designed to evaluate its efficacy and safety for cognitive deficits in schizophrenia, but the drug has not yet received regulatory approval.