Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
NCT ID: NCT00476931
Last Updated: 2012-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2007-05-31
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
SB-509
SB-509
60 mg dose
2
Placebo
Saline
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SB-509
60 mg dose
Placebo
Saline
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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).
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sangamo Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Coordinated Clinical Research
La Jolla, California, United States
Advanced Medical Research, LLC
Lakewood, California, United States
Torrance Clinical Research
Lomita, California, United States
SF Clinical Research Center
San Francisco, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Bradenton Research Center
Bradenton, Florida, United States
Neurology Clinical Research
Sunrise, Florida, United States
Laszlo J. Mate', M.D.
West Palm Beach, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Creighton Diabetes Center
Omaha, Nebraska, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Upstate Clinical Research
Albany, New York, United States
Peripheral Neuropathy Center, Weill Medical College of Cornell University
New York, New York, United States
Neurological Institute Columbia University College of Physicians and Surgeons
New York, New York, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Nerve and Muscle Center of Texas
Houston, Texas, United States
Diabetes Center of the Southwest
Midland, Texas, United States
DGD Research
San Antonio, Texas, United States
Rainier Clinical Research Center
Renton, Washington, United States
Instituto Mexicano de Investigación Clinica
Mexico City, Col. Roma, Mexico
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SB-509-0701
Identifier Type: -
Identifier Source: org_study_id