A PHASE III, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED,MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF VM202 IN SUBJECTS WITH PAINFUL DIABETIC PERIPHERAL NEUROPATHY
Sponsor: |
Viromed |
Enrolling: |
Male and Female Patients |
Study Length: |
9 Months |
Clinic Visits: |
11 |
IRB Number: |
AAAQ8820 |
U.S. Govt. ID: |
NCT02427464 |
Contact: |
Allan Paras: 2123056035 / ap3476@cumc.columbia.edu |
You are being considered to participate in this research study because you have type I or II diabetes with current treatment control and, you are experiencing painful diabetic peripheral neuropathy (DPN) in both lower extremities legs.The specific events that result in painful diabetic peripheral neuropathy are not well understood, but high blood sugar, reduced blood flow in the limbs, and changes in the blood vessels are thought to result in damage to the nerves in the affected areas. Stimulating the growth of new blood vessels may stimulate growth or regeneration of nerves and may reduce pain. Researchers have discovered that a protein called hepatocyte growth factor (HGF) that your body naturally produces in small amounts can cause the growth of new blood vessels and protect nerves. Unfortunately, your body only makes a small amount of this protein and not always in the areas where you need it. Researchers have found a way to increase the amount of HGF in your legs. They have isolated the genes responsible for directing the production of HGF, and have designed a product that can be injected into your leg.In the research study, the HGF gene will be injected into your calf muscle cells to evaluate if it changes your pain related to diabetic neuropathy. The product being used in this study is called VM202. VM202 is an experimental drug that is not yet approved by regulatory authorities (the US Food and Drug Administration FDA). VM202 is a plasmid (a small piece of DNA), which includes the HGF genes. VM202 is currently tested in the United States in subjects with Lou Gehrigs disease. VM202 has also been tested in people undergoing coronary bypass surgery. It is hoped that VM202 injected into your calf muscle will reduce pain related to diabetic neuropathy. This study is intended to help determine the safety and efficacy of VM202 in subjects with painful diabetic neuropathy. VM202 will be injected into both your calf muscles using a syringe with a fine needle.
This study is closed
Investigator
Thomas Brannagan, MD
Are you age 18 - 75? |
Yes |
No |
Do you have diabetes? |
Yes |
No |
Have you been told you have diabetic peripheral neuropathy or DPN? |
Yes |
No |
Is the pain/discomfort in both legs? |
Yes |
No |
Do you have any of the following: HIV, HTLV, Hepatitis B, or Hepatitis C? |
Yes |
No |