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MK0249

Phase 2

Paranoid Schizophrenia | Small molecule | Psychiatry |Merck & Company, Inc.|Last Updated: Aug 3, 2015

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 Enrollment55
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00506077MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)PHASE2 COMPLETED 55Dec 1, 2007Oct 1, 2008Aug 3, 2015 -
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Study Endpoints
Primary Endpoints
Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.
Baseline and 4 weeks of treatment

The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.

Secondary Endpoints
Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score
Baseline and 4 weeks of treatment
Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score
Baseline and 4 weeks of treatment
Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score
Baseline and 4 weeks of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK0249EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
MK0249DRUGMK0249 10mg (2 x 5 mg) tablet daily (qd) for 28 days.
Comparator: Placebo (unspecified)DRUGMK0249 10mg (2 x 5 mg) Pbo tablet qd for a 28 day treatment period.
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Eligibility Criteria
Age Range21 Years — 55 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months * Patient has a 6th grade reading level or better * Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth...

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