Recent Updates
Recently added Catalysts

BMS-954561

Phase 2

Post-Herpetic Neuralgia (PHN) | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Dec 7, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01305538Crossover Post-herpetic Neuralgia (PHN)PHASE2 COMPLETED 100Mar 1, 2011Jun 1, 2012Dec 7, 201523 United States, France
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.
up to 10 weeks
Secondary Endpoints
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Screening/Baseline Phase: Baseline
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Double-blind Treatment Phase: Weeks 1
Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.
Screening/Baseline Phase: Baseline
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1 BMS-954561 40mg or 80mgOTHERArm description: BMS-954561 40mg or 80mg three times daily (TID) to Placebo OR Placebo to 40mg or 80mg TID. Arm type: Active to Placebo or Placebo to Active (cross-over)
Arm 2 BMS-954561 150mg or 300mgOTHERArm description: BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Arm type: Active to Placebo or Placebo to Active(cross-over)
Interventions
NameTypeDescription
BMS-954561DRUG -
PlaceboDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Patient with Post-Herpetic Neuralgia (PHN) as defined as pain present for more than 6 months after the onset of a herpes zoster skin rash affecting the trigeminal, cervical, thoracic, lumbar, or sacral regions. * Based on patient diary information collected during the Baseline...

Countries:United StatesFrance
Unlock Eligibility Criteria