Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00406458
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2006-11-30
Brief Title:
Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
Sponsor:
Sangamo Therapeutics
Organization:
Sangamo Therapeutics
Study Overview
Official Title:
A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to study the clinical effects of the investigational drug SB-509 versus placebo in patients with diabetic neuropathy
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None