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Nepicastat

Phase 2

Posttraumatic Stress Disorder | Small molecule | Other |Johnson & Johnson|Last Updated: Oct 13, 2017

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00659230Nepicastat for Posttraumatic Stress Disorder (PTSD) in OIF/OEF VeteransPHASE2 COMPLETED 100Jul 1, 2009Aug 30, 2012Oct 13, 20173 United States
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Study Endpoints
Primary Endpoints
Clinician Administered PTSD Scale Subscore D (Hyperarousal)
Baseline, week 2, 4 and 6

The Clinician Administered PTSD Scale subscore D (CAPS-D) measures the hyperarousal cluster for PTSD symptoms (5 items). Higher scores indicate greater severity. Range for CAPS-D is zero to 40. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78).

Secondary Endpoints
Clinician Administered PTSD Scale Total Score
Baseline, week 2,4, and 6
Clinician Administered PTSD Scale Subscale B Score
6 weeks
Clinician Administered PTSD Scale Subscale C Score
Baseline, week 2, 4, and 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORArm 1
NepicastatACTIVE_COMPARATORArm 2
Interventions
NameTypeDescription
NepicastatDRUG100-800mg
PlaceboDRUG100-800mg placebo
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Eligibility Criteria
Age Range19 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Signed informed consent * Patient understands the risks and benefits and agrees to visit frequency and procedures * Male or female * Any race or ethnic origin * Served in OIF/OEF or Afghanistan conflicts or other Southwest Asia conditions * Currently Active Duty, National Guar...

Countries:United States
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