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BMS-741672

Phase 2

Neuropathic Pain | Small molecule | Neurology |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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00683423BMS-741672 for Diabetic Neuropathic PainPHASE2 COMPLETED 50Jul 1, 2008Feb 1, 2009Oct 12, 20158 United States
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Study Endpoints
Primary Endpoints
Reduction in weekly average pain score for BMS drug vs. placebo, computed from diary scores
recorded during the last 7 days of treatment in each period
Secondary Endpoints
Other glycemic, vascular, and mechanism-based biomarkers will be measured
throughout the study
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BMS-741672DRUGTablets, Oral, 100 mg, once daily, 3 weeks
PlaceboDRUGTablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Type 1 or 2 diabetics with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration * Screening HbA1c of ≥ 7% and ≤ 10% * BMI ≤ 40 kg/m2 Exclusion Criteria: * Patients with clinically significant, progressive, or potential...

Countries:United States
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