Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy - Full Text View

Sponsor:	Sangamo Biosciences
Information provided by:	Sangamo Biosciences
ClinicalTrials.gov Identifier:	NCT00476931

Purpose

The purpose of the study is to study the clinical effects of the investigational drug, SB-509 versus placebo in patients with diabetic neuropathy.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetic Polyneuropathy	Biological: SB-509 Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderate to Severe Diabetic Neuropathy and Unmeasurable Nerve Conduction Velocity

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1 Diabetic Nerve Problems

U.S. FDA Resources

Further study details as provided by Sangamo Biosciences:

Primary Outcome Measures:

Total Neuropathy Score (TNS),Evoked nerve conduction velocity (NCV), Quantitative Sensory Testing (QST), %of subjects with conversion of unmeasurable to measurable NCV and NIS-LL [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental SB-509	Biological: SB-509 60 mg dose
2: Placebo Comparator None	Other: Placebo Saline

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 moderate to severe 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.
Unmeasurable nerve conduction velocity in any lower extremity nerve: peroneal, tibial or sural due to diabetic polyneuropathy
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 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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476931

Locations

United States, California
Coordinated Clinical Research
La Jolla, California, United States, 92037
Diablo Clinical Research
Walnut Creek, California, United States, 94598
SF Clinical Research Center
San Francisco, California, United States, 94109
Advanced Medical Research, LLC
Lakewood, California, United States, 90712
Torrance Clinical Research
Lomita, California, United States, 90707
United States, Florida
Bradenton Research Center
Bradenton, Florida, United States, 34205
Neurology Clinical Research
Sunrise, Florida, United States, 33351
Laszlo J. Mate', M.D.
West Palm Beach, Florida, United States, 33407
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Nebraska
Creighton Diabetes Center
Omaha, Nebraska, United States, 68131
United States, Nevada
Advanced Biomedical Research of America
Las Vegas, Nevada, United States, 89123
United States, New York
Upstate Clinical Research
Albany, New York, United States, 12205
Peripheral Neuropathy Center, Weill Medical College of Cornell University
New York, New York, United States, 10022
Neurological Institute Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Texas
DGD Research
San Antonio, Texas, United States, 78229
Nerve and Muscle Center of Texas
Houston, Texas, United States, 77030
Diabetes Center of the Southwest
Midland, Texas, United States, 79705
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Mexico, Col. Roma
Instituto Mexicano de Investigación Clinica
Mexico City, Col. Roma, Mexico, 06700

Sponsors and Collaborators

Sangamo Biosciences

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sangamo BioSciences, Inc. ( Ely Benaim, M.D. , Vice President, Clinical Affairs )
Study ID Numbers:	SB-509-0701
Study First Received:	May 18, 2007
Last Updated:	September 22, 2009
ClinicalTrials.gov Identifier:	NCT00476931 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sangamo Biosciences:

Diabetic neuropathy
Diabetes Type 1 or 2
Moderate to severe sensorimotor diabetic polyneuropathy
Unmeasurable nerve conduction velocity

Additional relevant MeSH terms:

Metabolic Diseases
Autoimmune Diseases
Diabetic Neuropathies
Immune System Diseases
Nervous System Diseases
Diabetes Mellitus
Polyneuropathies

Endocrine System Diseases
Diabetes Mellitus, Type 1
Neuromuscular Diseases
Peripheral Nervous System Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Diabetes Complications

ClinicalTrials.gov processed this record on November 20, 2009