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ACP-103

Phase 2

Schizophrenia | Small molecule | Psychiatry |ACADIA Pharmaceuticals Inc.|Last Updated: Mar 22, 2007

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 Trials1
Total Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00361166Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and RisperidonePHASE2 COMPLETED 400Aug 1, 2005Mar 1, 2007Mar 22, 200717 United States, Brazil
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Study Endpoints
Primary Endpoints
Total score on the Positive and Negative Symptom Scale (PANSS).
Secondary Endpoints
Clinical Global Impression-Severity (CGI-S), Simpson Angus Scale (SAS), Barnes Akathisia Scale (BAS), Calgary Depression Scale for Schizophrenia (CDSS)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ACP-103DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * male or female subjects ages 18-65 diagnosed with schizophrenia * experiencing an acute exacerbation of psychosis * has had prior response to antipsychotic therapy within the previous 3 years * female subjects must be of non-childbearing potential or must comply with double-ba...

Countries:United StatesBrazil
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