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MK5757

Phase 2

Schizophrenia | Small molecule | Psychiatry |Merck & Company, Inc.|Last Updated: Nov 2, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

MK5757 · 1 trial · 1 indication

Phase 2 1
NCT00848484Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED)Schizophrenia
COMPLETED54 Analytics
PHASE2COMPLETED
Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED)
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment
Baseline and Week 2

The Brief Assessment of Cognition in Schizophrenia (BACS) was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The BACS composite score was calculated by averaging scores from the BACS subtests, including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Verbal Fluency (Semantic Fluency and Letter Fluency) and Tower of London. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -111.5 and 111.5, respectively.

Secondary Endpoints

Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score
Baseline and week 2
Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score
Baseline and Week 2
Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score
Baseline and Week 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMK5757
2PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
MK5757DRUGThis is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 25 mg capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 MK5757 50 mg capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days
Comparator: PlaceboDRUGThis is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 one placebo capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 two MK5757 placebo capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days.
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Eligibility Criteria

Age Range21 Years to 55 Years
SexMALE
Healthy VolunteersNo

Inclusion Criteria: * Patient is male between 21 and 55 years of age * Duration of the illness must be longer than 1 year * Patient's current antipsychotic medication regimen must be stable * Patient is negative for selected drugs of abuse at Screening * Must be in a stable living arrangement for a...

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Frequently asked questions about MK5757

What is MK5757 used for in schizophrenia?

MK5757 is an investigational small molecule being studied for the treatment of cognitive impairment in men with schizophrenia. It is in Phase 2 clinical development and is not yet approved by the FDA. The drug is being developed by Merck & Company, Inc. (MRK).

What does MK5757 target?

The specific molecular target of MK5757 has not been disclosed in the available information. The drug is a small molecule being investigated for its potential to treat cognitive impairment associated with schizophrenia, but its mechanism of action is not publicly detailed.

Who makes MK5757?

MK5757 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 2 clinical trials for schizophrenia-related cognitive impairment.

What phase is MK5757 in?

MK5757 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of cognitive impairment in men with schizophrenia, and its Phase 2 trial has been completed.

What clinical trials is MK5757 in?

MK5757 has one completed Phase 2 clinical trial registered as NCT00848484, titled 'Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)'. This randomized, double-blind, placebo-controlled study enrolled 54 male participants aged 21 years and older with schizophrenia.

Is MK5757 the same as any other drug?

No alternative names for MK5757 have been disclosed in the available information. The drug is identified solely by its development code MK5757 and is being studied by Merck & Company, Inc. for cognitive impairment in schizophrenia.