Clinical Trial of SB-509 in Subjects With Diabetic Neur...

Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

Clinical Trials for Diabetic Neuropathy

Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
This study is currently recruiting participants.
Verified by Sangamo Biosciences, December 2008
Sponsored by: 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

MedlinePlus related topics: Diabetes Diabetes Type 1 Diabetic Nerve Problems
Drug Information available for: Sodium chloride
U.S. FDA Resources
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

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:August 2009 (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 Recruiting
La Jolla, California, United States, 92037
Contact: Luci Barbi 858-455-5463 lbarbie@sandiegotrials.com
Principal Investigator: Jonathan Licht, M.D.
Diablo Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact: John McAdams 925-930-7267 jmcadams@diabloclinical.com
Contact: Bonnie Smith
Principal Investigator: Richard Weinstein, MD
SF Clinical Research Center Recruiting
San Francisco, California, United States, 94109
Contact: Jennifer Wong 415-673-4600 SFCRC@aol.com
Principal Investigator: Jerome Goldstein, M.D.
Advanced Medical Research, LLC Recruiting
Lakewood, California, United States, 90712
Contact: Ayman Ansari, MD 562-867-8195 amr@advmedresearch.com
Principal Investigator: Michael Perley, MD
United States, Florida
Bradenton Research Center Recruiting
Bradenton, Florida, United States, 34205
Contact: Carolyn McElveen 941-708-0005 cebmce@hotmail.com
Principal Investigator: Alvin McElveen, M.D.
Neurology Clinical Research Recruiting
Sunrise, Florida, United States, 33351
Contact: Pilar Hernandez, MD, CRC 954-475-8171 ext 145 phernandez@neuroresearch.net
Principal Investigator: Richard Singer, M.D.
Laszlo J. Mate', M.D. Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Mary Sergalis 561-882-0088 drmate@bellsouth.net
Principal Investigator: Laszlo Mate, M.D.
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Maureen Walsh 913-588-0645 mwalsh2@kumc.edu
Principal Investigator: Mamatha Pasnoor, M.D.
United States, Nebraska
Creighton Diabetes Center Recruiting
Omaha, Nebraska, United States, 68131
Contact: Jennifer Morre 402-280-5280 jenniferwells@creighton.edu
Principal Investigator: Mark Rendell, M.D.
United States, New York
Upstate Clinical Research Recruiting
Albany, New York, United States, 12205
Contact: Angela Finkle, RN 518-533-1500 afinkle@upstateneurology.com
Principal Investigator: James Wymer, MD
Peripheral Neuropathy Center, Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10022
Contact: Veronica Bedoya 212-888-8516 ext 123 vsb2001@med.cornell.edu
Principal Investigator: Jennifer Langsdorf, M.D.
United States, Pennsylvania
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Pam Pater 814-693-0300 ext 152 pamck24@aol.com
Principal Investigator: Alan Kivitz, M.D.
United States, Texas
DGD Research Recruiting
San Antonio, Texas, United States, 78229
Contact: Warren Douglas, LVN 210-615-5565 wdouglas@dgdclinic.com
Principal Investigator: Mark Kipnes, MD
Nerve and Muscle Center of Texas Recruiting
Houston, Texas, United States, 77030
Contact: Diana Nacy 713-795-0033 ext 27 Houston.neurocare@gmail.com
Principal Investigator: Aziz Shaibani, MD
Diabetes Center of the Southwest Recruiting
Midland, Texas, United States, 79705
Contact: Kathy M Sanchez 432-618-5226 transcript@dcosw.com
Principal Investigator: Gopalakrishna Murthy Gollapudi, M.D.
United States, Washington
Rainier Clinical Research Center Recruiting
Renton, Washington, United States, 98057
Contact: Rainier Clinical Research Center 888-478-8343 rcrc@rainier-research.com
Principal Investigator: Leslie Klaff, M.D.
Mexico, Col. Roma
Instituto Mexicano de Investigación Clinica Recruiting
Mexico City, Col. Roma, Mexico, 06700
Contact: Adolfo Dorenbaum (52) 55-5511-9111
Principal Investigator: Dra. Hiromi Rodríguez

Sponsors and Collaborators
Sangamo Biosciences

Responsible Party:Sangamo BioSciences, Inc. ( Ely Benaim, M.D. , Vice President, Clinical Affairs )
Study ID Numbers:SB-509-0701
First Received:May 18, 2007
Last Updated:December 10, 2008
ClinicalTrials.gov Identifier:NCT00476931 [history]
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

Study placed in the following topic categories:
Metabolic Diseases
Autoimmune Diseases
Diabetic Neuropathies
Polyneuropathies
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus, Type 1
Neuromuscular Diseases
Peripheral Nervous System Diseases
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Diabetes Complications

Additional relevant MeSH terms:
Immune System Diseases
Nervous System Diseases