Dose-effect of SSR180575 in Diabetic Neuropathy

Study Overview
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Brief Summary
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The primary objective of this sudy is to assess the effect of two doses of SSR180575 on the rate of regeneration of epidermal nerve fibers following denervation of the epidermal layer with capsaicin in patients with diabetes mellitus and mild peripheral neuropathy. Secondary objectives are to explore the efficacy of SSR180575 on clinical assessment, nerve function measures and to assess the tolerability and safety of SSR180575. The treatment period is 6 months.

Official Title
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A Multi-center, Randomized, Double-blind, Placebo Controlled Study of the Effect of SSR180575 at Two Doses for 24 Weeks Treatment on the Rate of Regeneration of Epidermal Nerve Fibers in Patients With Mild Diabetic Peripheral Neuropathy

Conditions
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Diabetic Neuropathies

Intervention / Treatment
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* Drug: SSR180575
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 randomization Patients with peripheral neuropathy attributable to any cause other than diabetes Non-measurable sural nerve sensory response on nerve conduction studies Amputation of any part of lower extremity Patients with a history of myocardial infarction or known coronary artery disease Grade III or IV heart failure on New York Heart Association criteria The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25 mg SSR180575<br>orally once daily for 24 weeks | Drug: SSR180575<br>* Oral, once daily dosing<br>|
| Experimental: 100 mg SSR180575<br>orally once daily for 24 weeks | Drug: SSR180575<br>* Oral, once daily dosing<br>|
| Placebo Comparator: Placebo<br>orally once daily for 24 weeks | Drug: Placebo<br>* Oral, once daily dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of epidermal nerve fiber regeneration |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Neuropathy