Dose-effect of SSR180575 in Diabetic Neuropathy

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502515

Enrollment

309

Registered

2007-07-17

Start date

2007-07-31

Completion date

2009-02-28

Last updated

2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies

Keywords

Diabetes, Neuropathy

Brief summary

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.

Interventions

DRUGSSR180575

Oral, once daily dosing

DRUGPlacebo

Oral, once daily dosing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Rate of epidermal nerve fiber regeneration	24 weeks

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026