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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00406458
Other study ID # SB-509-0601
Secondary ID
Status Completed
Phase Phase 2
First received November 30, 2006
Last updated October 30, 2012
Start date November 2006
Est. completion date May 2009

Study information

Verified date October 2012
Source Sangamo Biosciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date May 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Key Inclusion Criteria:

- Have a clinical diagnosis of diabetes mellitus type I or II for at least 12 months prior to the study.

- Have received a diagnosis of mild to moderate sensorimotor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes). This type of neuropathy is a loss of sensation and muscle function that occurs in the legs and hands in a stocking and glove distribution. Subjects with diabetic neuropathy that results in loss of sensation or muscle function in only one nerve and results in loss of nerve function of the blood vessels and causes low blood pressure, will not be eligible.

- If female and of childbearing potential, agree to use a medically acceptable physical barrier method during the study.

- Have blood pressure < 140/90 mm Hg

- Body mass index (BMI) < 38 kg/m2

Key Exclusion Criteria:

Subjects with the following are NOT eligible to participate in this study:

- Have moderate to severe ischemic heart disease, any history of congestive heart failure, or have had a myocardial infarction (heart attack) within the previous 6 months.

- Have chronic foot or leg ulcers for >1 month, gangrene in the legs, or any previous amputation of the lower extremity.

- Have symptoms of intermittent claudication (or leg pain during exercise associated with peripheral artery disease) and/or an ankle brachial index (or a calculation of the difference between arm and leg blood pressures) of less than (<) 0.75.

- Have a history of cancer within the past 5 years (except for curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years).

- Have colon polyps. If patients have a history of benign colonic polyps that have been removed, they must have evidence of a normal colonoscopy within the last 12 months.

- Require any drug that depresses patients' immune systems (such as methotrexate, cyclophosphamide, or cyclosporine) when they receive the study drug and for 30 days afterwards.

- Have a known disorder that affects patients' immune systems (such as HIV/AIDS, hepatitis B virus [HBV], hepatitis C virus [HCV], sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
SB-509
60 mg dose
Other:
Normal Saline


Locations

Country Name City State
Mexico Instituto Mexicano de Investigación Clinica Mexico City Col. Roma
United States Upstate Clinical Research Albany New York
United States Bradenton Research Center Bradenton Florida
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States Nerve and Muscle Center of Texas Houston Texas
United States University of Kansas Medical Center Kansas City Kansas
United States Coordinated Clinical Research La Jolla California
United States Advanced Medical Research, LLC Lakewood California
United States University of Miami, Diabetes Research Institute Miami Florida
United States Peripheral Neuropathy Center, Weill Medical College of Cornell University New York New York
United States Creighton Diabetes Center Omaha Nebraska
United States DGD Research San Antonio Texas
United States SF Clinical Research Center San Francisco California
United States Neurology Clinical Research Sunrise Florida
United States Diablo Clinical Research Walnut Creek California

Sponsors (2)

Lead Sponsor Collaborator
Sangamo Biosciences Juvenile Diabetes Research Foundation

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) One year No
Secondary Safety One year Yes
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