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SSR180575

Phase 2

Diabetic Neuropathies | Small molecule | Neurology |Sanofi|Last Updated: Aug 8, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment309

FDA Designations

No designations recorded

Clinical trial landscape

SSR180575 · 1 trial · 1 indication

Phase 2 1
NCT00502515Dose-effect of SSR180575 in Diabetic NeuropathyDiabetic Neuropathies
COMPLETED309 Analytics
PHASE2COMPLETED
Dose-effect of SSR180575 in Diabetic Neuropathy
Diabetic NeuropathiesUnlock trial analytics

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 to 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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Frequently asked questions about SSR180575

What is SSR180575 used for?

SSR180575 is an investigational small molecule being developed for diabetic neuropathies, a type of nerve damage caused by diabetes. It is currently in Phase 2 clinical development and has not been approved by the FDA.

Who makes SSR180575?

SSR180575 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 2 clinical trials for diabetic neuropathies.

What phase is SSR180575 in?

SSR180575 is in Phase 2 clinical development. It is an investigational drug for diabetic neuropathies and has not yet been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is SSR180575 in?

SSR180575 has one completed Phase 2 clinical trial, identified as NCT00502515, titled 'Dose-effect of SSR180575 in Diabetic Neuropathy'. This randomized, double-blind, placebo-controlled study enrolled 309 participants in the United States.

Is SSR180575 FDA approved?

No, SSR180575 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for diabetic neuropathies. The drug has completed one Phase 2 trial but has not yet received regulatory approval.