The purpose of the study is to study the clinical effects of the investigational drug, SB-509 versus placebo in patients with diabetic neuropathy.
SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a researcher injects SB-509 into your legs, the drug enters the muscle and nerve cells around the injection site and causes these cells to make a protein. This protein causes your cells to increase production of another protein called vascular endothelial growth factor (VEGF), which may improve the structure and function of nerves. In addition, there are changes in the levels of 28 additional proteins in your cells. These proteins function to promote the growth of cells, are structures in cells, help synthesize products, and affect immune cells, and some have unknown functions. This increase in your own VEGF proteins may protect and repair the damaged nerves caused by diabetic neuropathy. The study doctor will test SB-509 (60 mg) and placebo. Everyone in this study will receive intramuscular (IM-directly into the muscle) injections into both legs. This will happen 3 times over about 4 months. Two out of every 3 participants will receive SB-509 and 1 out of every 3 will receive placebo. You will not know, and the study doctor will not know, whether you will receive SB-509 or whether you will receive placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
60 mg dose
Coordinated Clinical Research
La Jolla, California, United States
Advanced Medical Research, LLC
Lakewood, California, United States
Visual analog scale for pain intensity (VASPI), Nerve Conduction Velocity (NCV), Total Neuropathy Score (TNS), Epidermal Nerve Fiber Density (ENFD) & Epidermal Nerve Fiber Density Regeneration (ENFDR)
Time frame: One year
Safety
Time frame: One year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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