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SSR180575

Phase 2

Diabetic Neuropathies | Small molecule | Neurology |Sanofi|Last Updated: Aug 8, 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_CONTROLLED
Total Trials1
Total Enrollment309
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00502515Dose-effect of SSR180575 in Diabetic NeuropathyPHASE2 COMPLETED 309 — — Jul 1, 2007Feb 1, 2009Aug 8, 20171 United States
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Study Endpoints
Primary Endpoints
Rate of epidermal nerve fiber regeneration
24 weeks
Secondary Endpoints
Efficacy: change between baseline and 24 weeks of peripheral neuropathy assessed with nerve conduction studies, clinical evaluation, Total Neuropathy Score
24 weeks
Safety: physical examination, clinical laboratories, adverse event reporting
24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
25 mg SSR180575EXPERIMENTALorally once daily for 24 weeks
100 mg SSR180575EXPERIMENTALorally once daily for 24 weeks
PlaceboPLACEBO_COMPARATORorally once daily for 24 weeks
Interventions
NameTypeDescription
SSR180575DRUGOral, once daily dosing
PlaceboDRUGOral, once daily dosing
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients diagnosed with Diabetes Mellitus, type I or II, treated or untreated * Diabetic neuropathy treated or untreated Exclusion Criteria: * Patients with unstable glycemic control * Patients who have been hospitalized for a diabetes complication in the 3 months prior to r...

Countries:United States
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