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SCA-136

Phase 2

Schizophrenia | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Aug 7, 2009

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-BlindUNCONTROLLEDBiomarker
Total Trials4
Total Enrollment412
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00265551Study Evaluating SCA-136 in Subjects With Acute Exacerbations of SchizophreniaPHASE2 COMPLETED 300Jan 1, 2006Jan 1, 2007Dec 10, 200735 United States
NCT00505973Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese Male SubjectsPHASE1 COMPLETED 24Jul 1, 2007Oct 1, 2007Dec 5, 20071 Japan
NCT00458107Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese and Non-Japanese Female SubjectsPHASE1 COMPLETED 64Apr 1, 2007Sep 1, 2007Dec 5, 20071 United States
NCT00447941Safety, PK and PD Study in Healthy Male Japanese SubjectsPHASE1 COMPLETED 24Jun 1, 2006Aug 1, 2006Aug 7, 2009 -
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Study Endpoints
Primary Endpoints
Change from baseline to day 42 on the positive subscale of the SCI-PANNS
Adverse events, safety laboratory results, vital signs, and ECGs will be used to monitor subject safety.
Adverse events, safety laboratories results, vital signs, and ECGs will be used to monitor subject safety.
safety and tolerability
Secondary Endpoints
Change from baseline to day 42 on:
SCI-PANNS total score
negative symptom sub-scale score of SCI-PANNS
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SCA-136 (200 mg)DRUG -
SCA-136 (400 mg)DRUG -
olanzapine (15 mg)DRUG -
placeboDRUG -
SCA-136DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Clinical diagnosis of schizophrenia * Ability to remain hospitalized for at least first 4 weeks of study * Needs hospitalization due to worsening of schizophrenia Exclusion Criteria: * Type 1 or 2 diabetes * Previous use of clozapine * Serious medical illness other than schi...

Countries:United StatesJapan
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