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pexacerfont

Phase 2

Generalized Anxiety Disorder | Small molecule | Psychiatry |Bristol-Myers Squibb Company|Last Updated: Oct 12, 2015

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_CONTROLLED
Total Trials1
Total Enrollment260
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00481325Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety DisorderPHASE2 COMPLETED 260 — — Jul 1, 2007Mar 1, 2008Oct 12, 201551 United States
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Study Endpoints
Primary Endpoints
Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)
Week 8
Secondary Endpoints
Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score
Week 8
Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score
Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A1EXPERIMENTAL -
A2ACTIVE_COMPARATOR -
A3PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
pexacerfontDRUGTablets \& Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
escitalopramDRUGTablets \& Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
placeboDRUGTablets \& Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites51

Inclusion Criteria: * Outpatient women ages 18-65 meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for Generalized Anxiety Disorder (GAD), either moderate or severe (300.02) Exclusion Criteria: * Males * Patients who report a...

Countries:United States
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