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Merck L-830982

Phase 2

Schizophrenia | Small molecule | Psychiatry |Merck & Company, Inc.|Last Updated: Oct 17, 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 Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00129441Gamma-Amino Butyric Acid (GABA)-A Alpha2/3 StudyPHASE2 COMPLETED 16Aug 1, 2005Jan 1, 2008Oct 17, 20111 United States
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Study Endpoints
Primary Endpoints
N-back Task - Reaction Time
Week 4

The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.

N-back Task - Error Rate
Week 4

The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.

AX Continuous Performance Test Task D-prime
Week 4

For the AX Continuous Performance Test, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.

Preparing to Overcome Prepotency (POP) Task - Reaction Time
Week 4

The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.

Preparing to Overcome Prepotency Task - Error Rate
Week 4

The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.

Secondary Endpoints
Brief Psychiatric Rating Scale Total Score
Week 4
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score
Week 4
Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex
Week 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Merck L-830982EXPERIMENTAL -
Sugar pillPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Merck L-830982DRUGThe initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
PlaceboDRUGMedications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male participants * Between the ages of 18 and 50 * Meet diagnostic criteria for schizophrenia or schizoaffective disorder * Are clinically stable for a minimum of 3 months on current dose of medication * Are unemployed (i.e., work less than 20 hours per week at competitive em...

Countries:United States
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